Answered from our dataUpdated October 4, 2026
Are red light therapy masks FDA cleared?
15 of the 47 red light therapy masks we list are named in an FDA 510(k) clearance.
Devices like these reach the market through a 510(k) clearance or a registration and listing; none of the devices we score holds FDA approval.
- 47 products behind this answer
- 17 brands
- updated October 4, 2026
Counted from the FDA status recorded for each product from FDA's own databases. How we score and check
FDA status, from FDA's records
- 510(k) cleared 15
- Registered or listed, not reviewed 23
- No FDA record names it 9
The 47 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
- Omnilux7here
- Solawave3here
- Shark2here
- Kala2here
- Therabody2here
- Dr. Dennis Gross3here
- HigherDOSE2here
- Bon Charge2here
- Glotech4here
- CurrentBody6here
- Qure2here
- Megelin4here
- iRestore4here
- Celluma1here
- Mito Red Light1here
- illumiflow1here
- Kiierr1here
Some links on this page earn us a commission. It never affects our scores or rankings. How this works
6th of 47 in LED Face & Neck Masks
510(k) cleared
10th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
12th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
13th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
15th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
16th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
17th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
17th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
17th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
21st of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
23rd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
24th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
26th of 47 in LED Face & Neck Masks
No FDA record names it
31st of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
32nd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
32nd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
32nd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
35th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
37th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
39th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
40th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
41st of 47 in LED Face & Neck Masks
No FDA record names it
42nd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
43rd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
44th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
45th of 47 in LED Face & Neck Masks
No FDA record names it
What this means
- FDA's record, not the maker's wording. Each status is read from FDA's own databases, by the device's model.
- Cleared is not approved. A 510(k) clearance means FDA accepted the device as substantially equivalent to one already on the market. None of the devices we score holds FDA approval.
- Registered or listed is not reviewed. A registration or listing involves no premarket review of the device.
The ranked lists
Every product we score in these categories, in order, with the reasons for each place.
Compare them head to head
Comparisons in LED Face & Neck Masks between products and brands in this answer.
Related questions
- Is red light therapy FDA approved? 56 of the 181 red light therapy devices we list are named in an FDA 510(k) clearance.
- Are red light therapy panels FDA cleared? Three of the 48 red light therapy panels we list are named in an FDA 510(k) clearance.
- Are laser caps for hair growth FDA cleared? 25 of the 40 laser hair growth devices we list are named in an FDA 510(k) clearance.
- Are red light therapy wraps FDA cleared? Four of the 20 red light wraps, pads and belts we list are named in an FDA 510(k) clearance.
- Are handheld red light devices FDA cleared? Nine of the 26 handheld red light devices we list are named in an FDA 510(k) clearance.
Counted from our data October 4, 2026 · · How we score · All answers