Answered from our dataUpdated October 4, 2026
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.
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.
- 40 products behind this answer
- 13 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 25
- Registered or listed, not reviewed 10
- No FDA record names it 5
The 40 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
- iRestore3here
- illumiflow5here
- Kiierr5here
- Capillus7here
- HairMax10here
- Qure1here
- Theradome2here
- HigherDOSE1here
- Glotech1here
- CurrentBody1here
- Revian2here
- Bon Charge1here
- Kala1here
Some links on this page earn us a commission. It never affects our scores or rankings. How this works
7th of 40 in Laser Hair Growth Caps & Helmets
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
13th of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
21st of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
23rd of 40 in Laser Hair Growth Caps & Helmets
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
31st of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
32nd of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
34th of 40 in Laser Hair Growth Caps & Helmets
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
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 Laser Hair Growth Caps & Helmets 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 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 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