510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OHSClass II

Light Based Over The Counter Wrinkle Reduction

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

OHS is the FDA product code for Light Based Over The Counter Wrinkle Reduction, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided". As of , FDA records hold 162 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
OHS
Device name
Light Based Over The Counter Wrinkle Reduction
FDA definition
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
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
163
Ingested recalls
4

Clearances, product code OHS

By decision year
163 clearances under product code OHS with a decision year between 2008 and 2026, 2025 the highest year at 42.
Show the numbers
510(k) clearances under FDA product code OHS by decision year
YearClearances
20082
20103
20112
20124
20132
20145
20154
20163
20178
20187
20194
20202
20217
202216
202312
202416
202542
202624

Applicants with the most clearances

Product code OHS
Applicants holding the most 510(k) clearances under product code OHS
ApplicantClearances
Shenzhen Kaiyan Medical Equipment Co., Ltd15
LED Technologies, Inc.11
Light Tree Ventures Europe B.V.7
LED Intellectual Properties LLC6
Guangdong Newdermo Biotech Co., Ltd4
Foreo Inc3
Premier North America, Inc3
Shenzhen Kaiyan Medical CO, Ltd.3
Shenzhen Qianyu Technology Co., Ltd.3
Shenzhen Ulike Smart Electronics Co.,Ltd3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 128 companies shown, in name order