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OHTClass II

Light Based Over-The-Counter Hair Removal

21 CFR 878.4810 / General, Plastic Surgery

OHT is the FDA product code for Light Based Over-The-Counter Hair Removal, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Over-the-counter device uses thermal energy to kill hair follicles for hair removal". As of , FDA records hold 163 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OHT
Device name
Light Based Over-The-Counter Hair Removal
FDA definition
Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
165
Ingested recalls
0

Clearances, product code OHT

By decision year
165 clearances under product code OHT with a decision year between 2006 and 2026, 2023 the highest year at 32.
Show the numbers
510(k) clearances under FDA product code OHT by decision year
YearClearances
20061
20101
20121
20132
20144
20152
20163
20176
20188
20197
20201
202112
202225
202332
202426
202525
20269

Applicants with the most clearances

Product code OHT

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 91 companies shown, in name order