Answered from our dataUpdated October 4, 2026

Is Kiierr FDA approved?

Two of the 11 Kiierr 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.

  • 11 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 2
  • Registered or listed, not reviewed 3
  • No FDA record names it 6

The 11 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

Kiierr 312 DualWave Laser Cap
Kiierr 312 $2,199

15th of 40 in Laser Hair Growth Caps & Helmets

Registered or listed, not reviewed
5.8
Kiierr 302 Ultra Flex Laser Cap
Kiierr 302 $1,799

24th of 40 in Laser Hair Growth Caps & Helmets

Registered or listed, not reviewed
5.2
Kiierr 272 DualWave Laser Cap
Kiierr 272 DualWave Laser Cap $1,499

27th of 40 in Laser Hair Growth Caps & Helmets

Registered or listed, not reviewed
5.1
Kiierr Revive LED Face Mask
Kiierr Revive LED Face Mask $399

47th of 47 in LED Face & Neck Masks

No FDA record names it
3.3
Kiierr Restore 4-in-1 LED Scalp Comb
Kiierr Restore 4-in-1 LED Scalp Comb $180

26th of 26 in Handheld Devices

No FDA record names it
2.5
Kiierr RH1500 Red Light Therapy Panel
Kiierr RH1500 $1,399 No FDA record names it
Kiierr RH2400 Red Light Therapy Panel
Kiierr RH2400 $1,899 No FDA record names it
Kiierr RH300 Red Light Therapy Panel
Kiierr RH300 $399 No FDA record names it
Kiierr RH3600 Red Light Therapy Panel
Kiierr RH3600 $2,399 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 Laser Hair Growth Caps & Helmets between products and brands in this answer.

Related questions

  • 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.
  • 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 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.

Counted from our data October 4, 2026 · · How we score · All answers

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