DeviceClearance

Product code OHS— General, Plastic Surgery

LED Facial Mask

Classification name
Light Based Over The Counter Wrinkle Reduction
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Total cleared
162
First cleared
Most recent

FDA classification definition

“Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.”

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

Market context for product code OHS

FDA has cleared 162 devices under product code OHS between 2008 and 2026, filed by 99 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 OHS

Adverse events under product code OHS

product code OHS
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OHS

1–100 of 162

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