FDA cleared red light therapy devices: how to check one

FDA cleared red light therapy devices are mostly LED face masks and handheld wands. Each one was cleared through a 510(k), the FDA’s “substantially equivalent” pathway for Class II devices. None is FDA approved. Most big red light panels are not cleared at all: they are listed as infrared heat lamps, which are exempt from review.

FDA cleared vs approved vs registered: what is the difference?

The three words mean different things, and companies sometimes blur them.

Term	What the FDA did	Applies to red light devices?
Approved (PMA)	Reviewed valid scientific evidence that the device is safe and effective	No. PMA is for high-risk Class III devices
Cleared (510(k))	Agreed the device is substantially equivalent to a device already on the market	Yes. Most masks and wands, plus laser hair combs
510(k)-exempt	Nothing before sale. The device type is exempt from premarket review	Yes. Panels listed as infrared heat lamps
Registered and listed	Nothing. The company told the FDA where it makes or sells the device	Every legal device, cleared or not

Premarket approval is “the most stringent type of device marketing application” and is required for Class III devices, the highest-risk group, such as those that support or sustain human life.¹ Red light masks are not in that class.

A 510(k) shows that a new device is “substantially equivalent” to a legally marketed one, called the predicate. It needs the same intended use and either the same technology or differences that do not raise new safety questions.² The FDA usually decides within 90 days.

Registration is weaker still. Federal rules state that registering an establishment “does not in any way denote approval” of it or its devices, and that implying official approval because of registration is misbranding.³ The same rule covers clearance: a 510(k) decision “does not in any way denote official approval of the device.”⁴ So “FDA approved red light therapy devices” is never an accurate label for a home mask or panel.

What class are red light therapy devices?

Home red light devices sit in Class II, but under several product codes. The code tells you what the clearance actually covers.

Product code	FDA name	Review path	Typical devices
OHS	Light based over the counter wrinkle reduction	510(k) required	LED face masks, wands
OLP	Over-the-counter powered light based laser for acne	510(k) required	Red and blue acne masks
OAP	Laser, comb, hair	510(k) required	Laser combs for pattern hair loss
ILY	Lamp, infrared, therapeutic heating	510(k) exempt	Most full-body and desk panels

OHS covers light treatment “to reduce wrinkles,” mostly on the face, head and neck. Its recognized standards include IEC 62471, the photobiological safety standard for lamps.⁵ OAP is for hair growth in men with androgenetic alopecia, Norwood-Hamilton IIa to V.⁶

ILY is the code that explains most panels. The regulation defines an infrared lamp as a device that emits infrared energy “to provide topical heating,” and exempts it from 510(k) review.⁷ That exemption has limits: a device intended for a use different from existing legally marketed devices loses it.⁸ A panel listed under ILY is registered as a heat lamp, with no FDA clearance for skin, hair, pain or sleep.

What does FDA clearance mean, and what does it not mean?

A clearance tells you three useful things. The maker submitted electrical and photobiological safety testing. Its marketing claims are supposed to stay within the cleared indication. And the FDA has a record of who makes it.

It does not tell you the device works. Equivalence is judged against a predicate, not against a sham or a placebo. The 510(k) summaries make this plain:

• The faceLITE mask summary (K191629) says: “Since the faceLITE LED mask raises no new questions in terms of safety and efficacy, clinical data is not required.”⁹
• The TheraFace Mask summary (K230293) says: “There were no clinical studies performed.”¹⁰
• The CurrentBody Series 2 summary (K250966) says: “Clinical testing is not needed for this 510(k).”¹¹

What those submissions contained instead was bench testing. The TheraFace summary, for example, lists medical electrical safety standards, IEC 62471 for light safety and skin-contact biocompatibility.¹⁰ The CryoGlow submission used the TheraFace Mask as its predicate. It added bench checks that its wavelengths and power density matched that mask, plus a human factors study of safe use.¹²

Clearance also covers one stated use. A mask cleared for full-face wrinkles is not cleared for sleep, mood, weight loss or hair growth, whatever the marketing says.

Does an FDA cleared red light mask actually work?

Modestly, for fine lines. A 2026 systematic review of at-home LED devices for facial aging found 8 studies with 365 participants in total, mostly using red and near-infrared light.¹³ Wrinkles, texture and elasticity improved, and side effects were infrequent, mild and short-lived. The authors flagged varied protocols, little head-to-head data and few participants with darker skin, and called for larger trials.

The single strongest trial for home masks is a 2025 double-blind study. Sixty adults of Asian descent, aged 30 to 65, used a 630 nm plus 850 nm LED mask or a sham mask for 16 weeks.¹⁴ Independent raters scored crow’s feet as better than sham at weeks 8, 12 and 16.

In a split-face trial of 137 women, 10 sessions over 4 weeks at 3.8 J/cm² cut periocular wrinkle volume by 31.6% on the red side and 29.9% on the amber side.¹⁵ There was no untreated side, so placebo effects cannot be ruled out. Skin hydration and elasticity did not change.

An earlier review of 37 trials of home dermatology devices recommended home LEDs for acne. For wrinkles, it recommended low-power radiofrequency devices instead.¹⁶ The LED wrinkle evidence has grown since, but it is still a grade B picture. For the full breakdown by use, see does red light therapy work.

How do you look up a device in the FDA 510(k) database?

The search takes about two minutes.

1. Open the FDA 510(k) Premarket Notification database on accessdata.fda.gov.
2. If the brand gives a K-number (a K followed by six digits), type it into “510K Number.” This is the fastest and most reliable route.
3. Otherwise, try “Device Name” with the brand or model, then “Applicant Name.” To list every wrinkle device, enter OHS in “Product Code.”
4. Open the result. Check the device name, the decision (“Substantially Equivalent”), the decision date and the product code.
5. Open the summary PDF. The “Indications for Use” page states exactly what the device is cleared to do.

A K-number record shows the essentials on one page. For K250966 it lists the CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H), applicant Shenzhen Kaiyan Medical Equipment, product code OHS, regulation 878.4810, and a decision date of June 25, 2025.¹¹

If the brand search finds nothing, do not assume the device is uncleared. Many masks are cleared under the factory’s name or a generic product name, then sold under a brand. The Omnilux Contour Face is an example: it is linked to K191629, which was cleared under the name faceLITE.¹⁷ Also search the brand in the Establishment Registration and Device Listing database, which shows the product code and, where one exists, the premarket number tied to it.

Watch for these red flags in marketing copy:

• “FDA approved” for a mask or panel.
• “FDA registered” or “Class II medical device” with no K-number.
• A K-number whose indication or product code does not match what the device claims to do.

FDA cleared red light therapy devices: masks and panels checked

Each device below was checked against FDA databases on October 20, 2026. K-numbers appear only where an FDA record ties them to the product. “Not confirmed” means no FDA record found links a K-number to that product. It does not mean the device is unsafe.

Device	FDA status	K-number and decision date	Cleared for
Shark CryoGlow LED mask	Cleared, Class II (OHS, OLP)	K242796, Nov 27, 2024	Fine lines and wrinkles; mild to moderate inflammatory acne
Therabody TheraFace Mask	Cleared, Class II (OHS, OLP)	K230293, Jun 9, 2023	Full-face wrinkles (red, red plus infrared); acne (blue)
CurrentBody Skin LED Mask Series 2 (MK-90H)	Cleared, Class II (OHS)	K250966, Jun 25, 2025	Full-face wrinkles
Omnilux Contour Face	Cleared, Class II (OHS)	K191629 (as faceLITE), Sep 12, 2019	Full-face wrinkles
HigherDOSE Red and Infrared Light Mask (MK66-L)	Cleared, Class II (OHS)	K241933, Sep 27, 2024	Full-face wrinkles
Kala Red Light Face Mask (KALA-01)	Cleared, Class II (OHS, OLP)	K250581, May 30, 2025	Full-face wrinkles (red, near-infrared); acne (blue)
LightStim for Wrinkles	Cleared, Class II	K261482, Jul 31, 2026	Full-face wrinkles
Dr. Dennis Gross DRx SpectraLite FaceWare	Not confirmed	Its FDA device identifier record lists no K-number	Not confirmed
Joovv Solo 3.0, Mini 3.0, Go 2.0	Listed as infrared heat lamp (ILY), 510(k)-exempt	None	Topical heating only
Mito Red MitoPRO series	Listed as infrared heat lamp (ILY), 510(k)-exempt	None	Topical heating only
PlatinumLED BioMax series	Listed as infrared heat lamp (ILY), 510(k)-exempt	None	Topical heating only
Bon Charge Max and Super Max panels	Listed as infrared heat lamp (ILY), 510(k)-exempt	None	Topical heating only

Sources: FDA 510(k) records and summaries,^910111218 FDA device identifier data,¹⁷ and FDA registration and listing records.¹⁹

Masks and wands, which make a specific wrinkle or acne claim, tend to be cleared. Large panels, which are sold for general wellness, tend to be registered as heat lamps. That does not make a panel worse at delivering light, but no FDA review stands behind any health claim made for it. Panels and masks are compared by output and wavelength on the red light therapy devices page.

Who should check with a doctor before using a red light device?

Clearance does not remove the need for basic caution. Read the cleared labeling, which lists the warnings for that device, and protect your eyes from bright LEDs.

Check with a doctor first if you take photosensitizing medication, such as some long-term acne antibiotics. A review found no published reports of laser complications in people on these drugs, but proposed a database of the wavelengths that activate each drug, for clinics to check before treatment.²⁰ Also ask first if you have an eye condition or a skin condition in the treatment area. More detail is in red light therapy risks.

If you are buying a device for sleep rather than skin, note that the clearances above cover wrinkles and acne, not sleep, and the sleep evidence is weak. See red light therapy for sleep before you spend money on that claim.

Footnotes

1. US Food and Drug Administration. Premarket approval (PMA). fda.gov ↩

2. US Food and Drug Administration. Premarket notification 510(k). fda.gov ↩

3. 21 CFR 807.39. Misbranding by reference to establishment registration or to registration number. law.cornell.edu ↩

4. 21 CFR 807.97. Misbranding by reference to premarket notification. law.cornell.edu ↩

5. US Food and Drug Administration. Product classification: light based over the counter wrinkle reduction (product code OHS, 21 CFR 878.4810). accessdata.fda.gov ↩

6. US Food and Drug Administration. Product classification: laser, comb, hair (product code OAP, 21 CFR 890.5500). accessdata.fda.gov ↩

7. 21 CFR 890.5500. Infrared lamp. law.cornell.edu; US Food and Drug Administration. Product classification: lamp, infrared, therapeutic heating (product code ILY). accessdata.fda.gov ↩

8. 21 CFR 890.9. Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act. law.cornell.edu ↩

9. US Food and Drug Administration. 510(k) clearance letter and summary, K191629, faceLITE. 2019. accessdata.fda.gov ↩ ↩²

10. US Food and Drug Administration. 510(k) clearance letter and summary, K230293, TheraFace Mask. 2023. accessdata.fda.gov ↩ ↩² ↩³

11. US Food and Drug Administration. 510(k) record K250966, CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H). 2025. accessdata.fda.gov; summary: accessdata.fda.gov ↩ ↩² ↩³

12. US Food and Drug Administration. 510(k) clearance letter and summary, K242796, CryoGlow. 2024. accessdata.fda.gov ↩ ↩²

13. Das RK, Thayer WP, Kubiak CA, et al. Efficacy and safety of at-home light-emitting diode photobiomodulation for facial rejuvenation: a systematic review. Aesthetic Plast Surg. 2026. doi:10.1007/s00266-026-06333-w ↩

14. Park SH, Park SO, Jung JA. Clinical study to evaluate the efficacy and safety of home-used LED and IRED mask for crow’s feet: a multi-center, randomized, double-blind, sham-controlled study. Medicine (Baltimore). 2025;104(7):e41596. doi:10.1097/MD.0000000000041596 ↩

15. Mota LR, Duarte IDS, Galache TR, et al. Photobiomodulation reduces periocular wrinkle volume by 30%: a randomized controlled trial. Photobiomodul Photomed Laser Surg. 2023;41(2):48-56. doi:10.1089/photob.2022.0114 ↩

16. Cohen M, Austin E, Masub N, et al. Home-based devices in dermatology: a systematic review of safety and efficacy. Arch Dermatol Res. 2022;314(3):239-246. doi:10.1007/s00403-021-02231-0 ↩

17. US Food and Drug Administration. Global Unique Device Identification Database records via openFDA: Omnilux Contour FACE (DI 05060534510128, premarket submission K191629) api.fda.gov; Drx SpectraLite Faceware (LED Technologies, no premarket submission listed) api.fda.gov ↩ ↩²

18. US Food and Drug Administration. 510(k) clearance letters and summaries: K241933, HIGHERDOSE Red and Infrared Light Mask (MK66-L), 2024 accessdata.fda.gov; K250581, KALA Red Light Face Mask (KALA-01), 2025 accessdata.fda.gov; K261482, LightStim for Wrinkles and LightStim for Acne, 2026 accessdata.fda.gov ↩

19. US Food and Drug Administration. Establishment Registration and Device Listing database, searches for Joovv, MitoPRO, BioMax Pro and Bon Charge Max (product code ILY). accessdata.fda.gov ↩

20. Kerstein RL, Lister T, Cole R. Laser therapy and photosensitive medication: a review of the evidence. Lasers Med Sci. 2014;29(4):1449-1452. doi:10.1007/s10103-014-1553-0 ↩