Answered from our dataUpdated October 4, 2026
Is red light therapy FDA approved?
56 of the 181 red light therapy devices 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.
- 181 products behind this answer
- 5 categories
- 26 brands
- updated October 4, 2026
Counted from the FDA status recorded for each product from FDA's own databases. How we score and check
By category
Where the products behind this answer sit. Each links to that category's ranked list.
FDA status, from FDA's records
- 510(k) cleared 56
- Registered or listed, not reviewed 83
- No FDA record names it 38
- Not cleared 4
The 181 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
- Omnilux8here
- Celluma6here
- Solawave6here
- iRestore10here
- Shark2here
- Kala10here
- Therabody4here
- illumiflow7here
- Kiierr11here
- Dr. Dennis Gross3here
- Capillus7here
- HigherDOSE5here
- HairMax10here
- Qure3here
- Bon Charge10here
- Theradome2here
- Glotech7here
- CurrentBody11here
- Revian2here
- PlatinumLED8here
- Mito Red Light16here
- Hooga18here
- Megelin10here
- Joovv3here
- Kineon1here
- Lumebox1here
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
7th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
4th of 18 in Wraps, Pads & Belts
510(k) cleared
5th of 18 in Wraps, Pads & Belts
510(k) cleared
30th of 43 in Red Light Therapy Panels
510(k) cleared
14th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
17th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
18th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
29th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
33rd of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
1st of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
4th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
7th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
8th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
11th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
12th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
14th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
18th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
18th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
20th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
20th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
10th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
23rd of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
23rd of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
26th of 43 in Red Light Therapy Panels
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
28th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
13th of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
31st of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
32nd of 43 in Red Light Therapy Panels
No FDA record names it
15th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
33rd of 43 in Red Light Therapy Panels
No FDA record names it
16th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
34th of 43 in Red Light Therapy Panels
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
35th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
37th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
21st of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
21st of 40 in Laser Hair Growth Caps & Helmets
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
9th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
23rd of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
31st of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
27th of 40 in Laser Hair Growth Caps & Helmets
No FDA record names it
27th of 40 in Laser Hair Growth Caps & Helmets
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
10th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
11th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
31st of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
35th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
32nd of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
12th of 18 in Wraps, Pads & Belts
No FDA record names it
11th of 26 in Handheld Devices
No FDA record names it
12th of 26 in Handheld Devices
Registered or listed, not reviewed
37th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
13th of 26 in Handheld Devices
Registered or listed, not reviewed
39th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
39th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
40th of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
40th of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
34th of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
14th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
41st of 47 in LED Face & Neck Masks
No FDA record names it
16th of 26 in Handheld Devices
Registered or listed, not reviewed
42nd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
36th of 40 in Laser Hair Growth Caps & Helmets
No FDA record names it
37th of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
15th of 18 in Wraps, Pads & Belts
No FDA record names it
15th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
43rd of 47 in LED Face & Neck Masks
Registered or listed, not reviewed
17th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
18th of 18 in Wraps, Pads & Belts
No FDA record names it
18th of 26 in Handheld Devices
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
41st of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
42nd of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
23rd of 26 in Handheld Devices
No FDA record names it
24th of 26 in Handheld Devices
No FDA record names it
25th of 26 in Handheld Devices
No FDA record names it
43rd of 43 in Red Light Therapy Panels
Registered or listed, not reviewed
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.
2
3
The best red light therapy panels
First: PlatinumLED BIOMAX PRO ULTRA Red Light Therapy Panel. Top 10 of 43 scored, 4 October 2026.
See the ranking
1
2
3
The best red light therapy masks
First: Omnilux Contour Face. Top 10 of 47 scored, 4 October 2026.
See the ranking
1
2
3
The best laser hair growth caps and helmets
First: iRestore Elite. Top 10 of 40 scored, 4 October 2026.
See the ranking
Compare them head to head
Comparisons in Red Light Therapy Panels between products and brands in this answer.
Related questions
- 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.
- 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