Answered from our dataUpdated October 4, 2026
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.
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.
- 26 products behind this answer
- 16 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 9
- Registered or listed, not reviewed 5
- No FDA record names it 12
The 26 products behind this answer
Best overall score first. Each links to its full review, where the score is broken down.
- Solawave3here
- Therabody1here
- Kala2here
- Celluma1here
- HigherDOSE1here
- Glotech2here
- Hooga4here
- PlatinumLED1here
- Bon Charge3here
- Mito Red Light1here
- CurrentBody1here
- Joovv1here
- Lumebox1here
- Megelin2here
- illumiflow1here
- Kiierr1here
Some links on this page earn us a commission. It never affects our scores or rankings. How this works
11th of 26 in Handheld Devices
No FDA record names it
12th of 26 in Handheld Devices
Registered or listed, not reviewed
13th of 26 in Handheld Devices
Registered or listed, not reviewed
16th of 26 in Handheld Devices
Registered or listed, not reviewed
18th of 26 in Handheld Devices
Registered or listed, not reviewed
23rd of 26 in Handheld Devices
No FDA record names it
24th of 26 in Handheld Devices
No FDA record names it
25th of 26 in Handheld Devices
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.
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Counted from our data October 4, 2026 · · How we score · All answers