Answered from our dataUpdated October 4, 2026
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.
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.
- 20 products behind this answer
- 12 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 4
- Registered or listed, not reviewed 10
- No FDA record names it 4
- Not cleared 2
The 20 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
- Omnilux1here
- iRestore2here
- Celluma2here
- Hooga3here
- Kala1here
- Mito Red Light2here
- HigherDOSE1here
- Megelin4here
- CurrentBody1here
- Kineon1here
- Bon Charge1here
- Therabody1here
Some links on this page earn us a commission. It never affects our scores or rankings. How this works
4th of 18 in Wraps, Pads & Belts
510(k) cleared
5th of 18 in Wraps, Pads & Belts
510(k) cleared
9th of 18 in Wraps, Pads & Belts
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
12th of 18 in Wraps, Pads & Belts
No FDA record names it
14th of 18 in Wraps, Pads & Belts
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
17th of 18 in Wraps, Pads & Belts
Registered or listed, not reviewed
18th of 18 in Wraps, Pads & Belts
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.
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.
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- 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.
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- 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