Answered from our dataUpdated October 4, 2026
Is iRestore FDA approved?
Four of the 10 iRestore 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
- 4 categories
- 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 4
- Registered or listed, not reviewed 2
- No FDA record names it 4
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
7th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
29th of 40 in Laser Hair Growth Caps & Helmets
510(k) cleared
40th 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 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
1
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
Compare them head to head
Comparisons in LED Face & Neck Masks between products and brands in this answer.
Related questions
- Is iRestore good? We list 10 iRestore products and score nine of them. Their overall scores run from 4.7 to 8.2, with a median of 5.2, 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