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Red light therapy: FDA cleared or only registered? 18 devices checked against FDA records

“FDA cleared” means FDA issued a 510(k) for the device. “FDA registered” or “listed” means the maker filed the device with FDA, which isn’t clearance or approval. This page sets what 18 red light devices say about FDA beside what FDA’s databases show, checked November 6, 2026.

By Explainer Updated

The bottom line

Five of the 18 devices have a 510(k) under their own name or model. Two more are tied to a 510(k) only through FDA’s listing records, and one is unconfirmed. The other 10 are listed under an exempt category or have no record we could find. A listing isn’t clearance.

See our red-light therapy picks →

Our reviews rest on published sources, not hands-on testing. Our method

Porsche also cofounded Superhuman Chambers, which sells hyperbaric chambers · About the author. This is general information, not medical advice, and no clinician has reviewed it.

Stock photo: Max Kolganov / Unsplash

In this article

What “FDA cleared” and “FDA registered” mean

FDA clears most low-risk devices through a 510(k), a submission showing the new device is as safe and effective as one already legally sold1. The result is a K-number you can look up, and the clearance covers a stated use. A mask cleared for full-face wrinkles isn’t cleared for anything else.

Registration and listing is a different record. Makers file it to tell FDA about a device and where it is made. FDA’s rules say registration or a registration number does not denote approval of the company or its products, and implying it does is misleading2.

Many red light panels sell under product code ILY, “lamp, infrared, therapeutic heating.” FDA classes it Class II but exempts it from 510(k), so a panel in that category is listed and not cleared3. A maker that calls a panel “Class II” or “FDA registered” is describing that category. For what a clearance does and doesn’t show about results, read Does red light therapy work?.

What each phrase means and where to check it
Phrase on a product pageWhat it meansWhere to check
FDA clearedFDA issued a 510(k) for that device and use1510(k) database, by K-number or name5
FDA approvedA premarket approval, a separate route from a 510(k)1FDA premarket approval database
FDA registered or listedThe maker or factory filed the device with FDA. It is not approval or clearance2Registration and listing database6, or AccessGUDID7
Class IIFDA’s risk class for the product code. Some Class II codes need a 510(k), and ILY does not3FDA product classification database

Devices with a matching 510(k)

Five devices match a 510(k) by name or model. All sit under primary product code OHS, light based over-the-counter wrinkle reduction4. The cleared use is narrow: full-face wrinkles for the four masks, and red light for wrinkles on the face for the Solawave wand. The TheraFace Mask also has blue light cleared for mild to moderate inflammatory acne. For the Solawave wand’s record set against the masks’ on price, coverage and warranty, see the wand-versus-mask comparison.

None of the reviews records a K-number on a maker’s page, so each match rests on FDA’s own records. Omnilux’s clearance is filed as faceLITE, and FDA’s device record lists Contour FACE, model TN19G, under K1916291023. K072459 is a different record: Omnilux New-U, cleared in 200818.

Three of the five clearances were filed by one applicant, Shenzhen Kaiyan Medical Equipment Co., Ltd., for the HigherDOSE, CurrentBody and Solawave devices. The same company filed Kala’s mask, wand and Mini 2.0891219. A brand name on the box and the name on the filing often differ.

Red light devices with a matching 510(k), checked November 6, 2026
Device510(k)FDA record name and applicantProduct codeCleared forDecision dateWhat the maker says
CurrentBody Skin LED Mask Series 2K2509668CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H), Shenzhen Kaiyan Medical Equipment Co., Ltd.OHSOver-the-counter use, full-face wrinklesJun 25, 2025Not recorded in our review
HigherDOSE Red Light Face MaskK2419339HIGHERDOSE Red and Infrared Light Mask (MK66-L), Shenzhen Kaiyan Medical Equipment Co., Ltd.OHSOver-the-counter use, full-face wrinklesSep 27, 2024Page title says FDA cleared. No K-number41
Omnilux Contour FaceK19162910faceLITE, Ismart Marketing Svcs, Ltd. FDA’s device record lists Contour FACE, model TN19G, under this numberOHSOver-the-counter use, full-face wrinklesSep 12, 2019Says FDA cleared for full-face wrinkles. No K-number or model number39
Therabody TheraFace MaskK23029311TheraFace Mask, Therabody, Inc.OHSRed and red plus infrared light: full-face wrinkles. Blue light: mild to moderate inflammatory acneJun 9, 2023Not recorded in our review
Solawave 4-in-1 Skincare WandK23286312Radiant Renewal Skincare Wand (HD-15, HD-15A), Shenzhen Kaiyan Medical Equipment Co., Ltd. FDA’s device record lists Solawave model HD-15A under this numberOHSRed light: wrinkles on the face. HD-15A: over-the-counter cosmetic facial and neck stimulationDec 13, 2023Calls the wand an FDA-cleared medical device42

Cleared under another name, or not confirmed

Three devices have a gap between the maker’s wording and FDA’s device record. Celluma’s and Omnilux Men’s records are linked to 510(k)s through FDA’s listing database. The Dr. Dennis Gross FaceWare Pro has no 510(k) under its name, and neither the brand nor FDA ties it to one.

The Omnilux Men’s point matters because the 510(k) it is filed under describes 630 and 830 nm LEDs, and the Men’s mask adds 1072 nm light22. We make no claim about what that means. It only shows the clearance wasn’t written for that wavelength. Omnilux Men vs Contour Face answers the buying question between the two Omnilux masks.

Devices whose FDA record sits under another name or is unconfirmed, checked November 6, 2026
DeviceWhat the maker saysWhat FDA’s records showWhere that leaves it
Celluma PRO PLUSLists acne, aging, contour and pain as the FDA-cleared modes43No 510(k) is named PRO PLUS. FDA’s listing database links “Celluma Series 2 PRO PLUS” to three: K152280 (Celluma3, Mar 2, 2016: heat for minor muscle and joint pain, blue light for acne, red and infrared light for periorbital wrinkles)13, K171323 (Celluma3, Sep 1, 2017: full-face wrinkles)14 and K232977 (Celluma CONTOUR, Nov 21, 2023: circumference of hips, waist and thighs, plus the heat and pain use)1530Tied to three 510(k)s by FDA’s listing, none under its own name
Omnilux MenSays FDA cleared for full-face wrinkles40The device record for model TN2227 shows product codes OHS and ILY and no 510(k) number24. The listing database files the Omnilux Mens name under K191629, the faceLITE clearance1031. No iSMART 510(k) names the Men’s mask or model TN222738Linked to K191629 in one FDA record, with no 510(k) in its device record
Dr. Dennis Gross FaceWare ProCalls it FDA-cleared and gives no K-number44No 510(k) is named FaceWare Pro. The nearest are LED Technologies’ dpl Faceware, K183247 (Mar 14, 2019)16, and dpl SpectraLite, K171386 (Aug 7, 2017)17, both product code OHS. None of seven Dr Dennis Gross device records from LED Technologies shows a 510(k) number28Clearance for this model unconfirmed

Listed with FDA, with no 510(k)

The 10 devices below are filed under ILY or have no FDA record we could find. Under ILY a listing is expected and no 510(k) is needed3. A listing isn’t clearance, and none of these has one.

Two rows stand out. Kala’s page shows an “FDA Cleared” badge, but the 510(k)s FDA lists under the Kala name cover a face mask, a therapy wand and the Mini 2.0, not the Elite panel192145. Hooga says its panels are listed through its manufacturing partner, and we found no Hooga entry in the databases we searched, so that statement can’t be checked49. For the four small devices (Lumebox, MitoPRO 300X, BIOMAX 300 and Celluma) in one table, see the small-device comparison.

Panels and handhelds with no 510(k) on record, checked November 6, 2026
DeviceWhat the maker saysWhat FDA’s records showRecord type
Joovv Solo 3.0Labels it a Class II medical device and cites Intertek testing to IEC 60601. The page doesn’t mention FDA clearance50Joovv, Inc., model PT500-F0486, product code ILY, over the counter, no premarket submission25. “Joovv Solo 3” listed under ILY36Listed under ILY
Kala Red Light Elite PanelShows an “FDA Cleared” badge and lists FDA under certifications45Brand “LED RED LIGHT,” model “KALA Elite,” Shenzhen Saidi Light Therapy Technology Co., Ltd., product code ILY, over the counter, no premarket submission26Device record under ILY
Lumebox 2.0Says it is registered with FDA as a Class II medical device46Lumebox, made by Dongguan Heron Opto Co., Ltd., product code ILY, no 510(k) number35. Device record for model LB-001A shows ILY only27Listed under ILY
MitoPRO 300XCalls the MitoPRO X “FDA Class II Registered”47Mito Red Light LLC lists the MitoPRO X Series under ILY with no 510(k) number. The K-numbers on Mito’s other listings belong to the MitoGLOW Mask (K221775), MitoGROW (K222477) and MitoCLEAR (K240089)32Listed under ILY
MitoPRO 750XSame wording as the 300XSame listing as the 300XListed under ILY
MitoPRO 1500XSame wording as the 300XSame listing as the 300XListed under ILY
PlatinumLED BIOMAX 300No FDA clearance claim recorded in our reviewPlatinum LED Holdings LLC lists BIOMAX 300 under ILY, and its contract manufacturer E.Shine Systems Limited lists BIOMAX300. Neither listing has a 510(k) number33Listed under ILY
PlatinumLED BIOMAX 900No FDA clearance claim recorded in our reviewSame two listings as the BIOMAX 300, with BIOMAX 900 and BIOMAX900Listed under ILY
BON CHARGE Super MaxCalls it an “FDA Class II registered device” and says all its red light devices are registered48BLUBLOX PTY LTD, trading as BON CHARGE, lists the Super Max Red Light Therapy Device (SG-DP) under ILY with no 510(k) number34Listed under ILY
Hooga HGPRO1500Says its panels are listed under its manufacturing partner’s registration, under ILY, as a listing and not 510(k) clearance49No entry under the Hooga or HGPRO names in AccessGUDID or in the registration and listing database2937Nothing found

How we checked, and how to check one yourself

On November 6, 2026 we searched FDA’s 510(k) data by device name and applicant, read the 510(k) entries and summaries for each K-number above, and searched the registration and listing and GUDID databases by brand and model57. openFDA’s 510(k) and listing data were last updated October 26, 2026. We opened the AccessGUDID records directly. The makers’ wording is from each review’s product page check between October 13 and 30, 2026. The Dr. Dennis Gross and Kala pages were rechecked November 6.

A missing record means we found none, not that none exists. FDA databases lag, and a brand can sell a device filed under a different name or company. If you spot a record we missed, the corrections page tells you how to reach us.

To check a device yourself:

  • Search the 510(k) database for the brand, then for the company that makes it. Open the entry and read the indications for use5.
  • Match the model number, not just the brand. A K-number belongs to the model named on the filing.
  • If the product page gives no K-number, search the registration and listing database and AccessGUDID for the model. A record that shows only product code ILY has no 510(k) to find67.
  • Compare the cleared use with the claim on the page. A clearance for wrinkles doesn’t cover recovery, pain or hair.

What this page does not show

This is a record check. It does not say whether any device works, and a missing 510(k) does not mean a device is unsafe. A clearance shows FDA found a device substantially equivalent to an earlier one for a stated use. For what the studies found, read Does red light therapy work?.

For how we weigh FDA status against output, warranty and returns, see how we choose red light devices. For the masks side by side, see best red light therapy masks compared and the panel comparison.

Using this data

To cite this page: Biology Verdict, “Red light therapy: FDA cleared or only registered? 18 devices checked against FDA records”, https://biologyverdict.com/pages/red-light-fda-cleared-or-registered, data as of November 7, 2026.

Each row reports what we found in FDA’s 510(k), registration and listing, and AccessGUDID databases, and the K-numbers let you open the FDA’s own entry. For the official record, cite FDA’s database entry57. A missing record means we found none, not that none exists.

There is no fixed schedule. We search the records again when we update a device’s review or when a reader reports a record we missed, and the date above is the last time the whole table was checked.

Our terms of use let you link to any page and quote short passages with a link back. They don’t allow republishing whole pages or copying the site’s content in bulk, and we haven’t set a separate licence. Please credit Biology Verdict and link this page. For a question, a correction or a larger request, write to hello@biologyverdict.com.

Keep reading

Lumebox vs MitoPRO 300X vs BIOMAX 300 vs Celluma: small red light therapy devices comparedRed-light therapy buying guideDoes red light therapy work? What the studies showHow we choose red light devicesBest red light therapy masks comparedRed-light panel comparisonRed light therapy dangers: eye risks, flicker and EMF for 18 devicesOmnilux Men vs Contour Face: 1072 nm light and FDA record comparedHigherDOSE vs OmniluxJoovv vs Mito Red LightMitoPRO reviewOmnilux vs CurrentBodySolawave wand vs a red light face mask

Sources

  1. Premarket Notification 510(k) US Food and Drug Administration, 2024 · regulator
  2. 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number Electronic Code of Federal Regulations · regulator
  3. Product classification: lamp, infrared, therapeutic heating (product code ILY) US Food and Drug Administration · regulator
  4. Product classification: light based over the counter wrinkle reduction (product code OHS) US Food and Drug Administration · regulator
  5. 510(k) Premarket Notification database US Food and Drug Administration · regulator
  6. Establishment Registration and Device Listing database US Food and Drug Administration · regulator
  7. AccessGUDID: Global Unique Device Identification Database US National Library of Medicine and FDA · regulator
  8. 510(k) Premarket Notification K250966: CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H) US Food and Drug Administration · regulator
  9. 510(k) Premarket Notification K241933: HIGHERDOSE Red and Infrared Light Mask (MK66-L) US Food and Drug Administration · regulator
  10. 510(k) Premarket Notification K191629: faceLITE US Food and Drug Administration · regulator
  11. 510(k) Premarket Notification K230293: TheraFace Mask US Food and Drug Administration · regulator
  12. 510(k) Premarket Notification K232863: Radiant Renewal Skincare Wand (HD-15, HD-15A) US Food and Drug Administration · regulator
  13. 510(k) Premarket Notification K152280: BioPhotas Celluma3 US Food and Drug Administration · regulator
  14. 510(k) Premarket Notification K171323: BIOPHOTAS CELLUMA3 US Food and Drug Administration · regulator
  15. 510(k) Premarket Notification K232977: Biophotas Celluma CONTOUR US Food and Drug Administration · regulator
  16. 510(k) Premarket Notification K183247: dpl Faceware US Food and Drug Administration · regulator
  17. 510(k) Premarket Notification K171386: dpl SpectraLite US Food and Drug Administration · regulator
  18. 510(k) Premarket Notification K072459: OMNILUX NEW-U US Food and Drug Administration · regulator
  19. 510(k) Premarket Notification K250581: KALA Red Light Face Mask (KALA-01) US Food and Drug Administration · regulator
  20. 510(k) Premarket Notification K250761: KALA Therapy Wand (KALA-03) US Food and Drug Administration · regulator
  21. 510(k) Premarket Notification K251781: KALA MINI 2.0 (KALA-04) US Food and Drug Administration · regulator
  22. K191629 510(k) summary and indications for use: faceLITE LED mask US Food and Drug Administration, 2019 · regulator
  23. AccessGUDID device record: Omnilux Contour FACE, model TN19G US National Library of Medicine and FDA · regulator
  24. AccessGUDID device record: Omnilux Men's, model TN2227 US National Library of Medicine and FDA · regulator
  25. AccessGUDID device record: Joovv Solo 3.0 US National Library of Medicine and FDA · regulator
  26. AccessGUDID device record: LED RED LIGHT, KALA Elite US National Library of Medicine and FDA · regulator
  27. AccessGUDID device record: LUMEBOX, model LB-001A US National Library of Medicine and FDA · regulator
  28. openFDA GUDID search: LED Technologies devices branded Dr Dennis Gross US Food and Drug Administration (openFDA), 2026 · regulator · data file
  29. AccessGUDID search: hooga (0 results on Nov 6, 2026) US National Library of Medicine and FDA, 2026 · regulator
  30. openFDA registration and listing search: Celluma US Food and Drug Administration (openFDA), 2026 · regulator · data file
  31. openFDA registration and listing search: Omnilux Mens US Food and Drug Administration (openFDA), 2026 · regulator · data file
  32. openFDA registration and listing search: Mito Red Light LLC US Food and Drug Administration (openFDA), 2026 · regulator · data file
  33. openFDA registration and listing search: BIOMAX (Platinum LED Holdings LLC and E.Shine Systems Limited) US Food and Drug Administration (openFDA), 2026 · regulator · data file
  34. openFDA registration and listing search: BLUBLOX PTY LTD (BON CHARGE) US Food and Drug Administration (openFDA), 2026 · regulator · data file
  35. openFDA registration and listing search: Lumebox US Food and Drug Administration (openFDA), 2026 · regulator · data file
  36. openFDA registration and listing search: Joovv US Food and Drug Administration (openFDA), 2026 · regulator · data file
  37. openFDA registration and listing search: Hooga (no matches on Nov 6, 2026) US Food and Drug Administration (openFDA), 2026 · regulator · data file
  38. openFDA 510(k) search: applicant iSMART US Food and Drug Administration (openFDA), 2026 · regulator · data file
  39. Omnilux Contour Face Omnilux · manufacturer
  40. Omnilux Men Omnilux · manufacturer
  41. Red Light Therapy Face Mask - FDA Cleared HigherDOSE · manufacturer
  42. Radiant Renewal Skincare Wand Benefits & Contraindications Solawave · manufacturer
  43. Celluma PRO PLUS Celluma · manufacturer
  44. DRx SpectraLite FaceWare Pro 3-Minute LED Device Dr. Dennis Gross Skincare · manufacturer
  45. Kala Red Light Elite Panel Kala · manufacturer
  46. Frequently Asked Questions About Lumebox Lumebox · manufacturer
  47. MitoPRO X | Red Light Therapy Panel Series (MitoPRO 750X) Mito Red Light · manufacturer
  48. Super Max Red Light Therapy Device BON CHARGE · manufacturer
  49. Quality and certifications Hooga · manufacturer
  50. Joovv Solo 3.0 | Full Body LED Red Light Therapy Device Joovv · manufacturer

How this was written. Written from the sources listed above, checked . It is general information, not medical advice. Talk to a clinician before acting on anything here if you have a health condition or take medication.

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