Answered from our dataUpdated October 4, 2026
Is HairMax FDA approved?
Eight of the 10 HairMax 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.
- 10 products behind this answer
- 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 8
- Registered or listed, not reviewed 2
The 10 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
Some links on this page earn us a commission. It never affects our scores or rankings. How this works
17th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
18th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
31st of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewed
37th of 40 in Laser Hair Growth Caps & Helmets
Registered or listed, not reviewedWhat 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 HairMax good? We list 10 HairMax products and score 10 of them. Their overall scores run from 4.1 to 7.0, with a median of 5.6, against a median of 5.5 for all 174 products we score.
- Is Omnilux good? We list eight Omnilux products and score eight of them. Their overall scores run from 4.7 to 9.0, with a median of 6.4, against a median of 5.5 for all 174 products we score.
- Is Omnilux FDA approved? Five of the 8 Omnilux devices we list are named in an FDA 510(k) clearance.
- Is CurrentBody good? We list 11 CurrentBody products and score 10 of them. Their overall scores run from 4.6 to 6.5, with a median of 5.6, against a median of 5.5 for all 174 products we score.
- Is CurrentBody FDA approved? Three of the 11 CurrentBody devices we list are named in an FDA 510(k) clearance.
- Is Kiierr good? We list 11 Kiierr products and score seven of them. Their overall scores run from 2.5 to 7.6, with a median of 5.2, against a median of 5.5 for all 174 products we score.
Counted from our data October 4, 2026 · · How we score · All answers