DeviceClearance

Product code OHT— General, Plastic Surgery

IPL Hair Removal Device

Classification name
Light Based Over-The-Counter Hair Removal
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
167
First cleared
Most recent

FDA classification definition

“Over-the-counter device uses thermal energy to kill hair follicles for hair removal.”

— U.S. Food and Drug Administration, device classification record for product code OHT under 21 CFR 878.4810, via openFDA

Market context for product code OHT

FDA has cleared 167 devices under product code OHT between 2006 and 2026, filed by 83 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code OHT

Recent clearances under product code OHT

1–100 of 167

Data sourced from openFDA. This site is unofficial and independent of the FDA.