510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K260767Substantially Equivalent

Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

Kam Yuen Plastic Products , Ltd., Zhongshan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(175 days to decision)
Product code
OHS Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kam Yuen Plastic Products , Ltd. # 2, Heng Feng Two Rd., Pu Jin Industrial, Konghou Town, Zhongshan, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OHS

Trailing 12 months
35 clearances under product code OHS in the twelve months to October 2026, December 2025 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code OHS, trailing twelve months
MonthClearances
November 20253
December 20258
January 20263
February 20262
March 20264
April 20261
May 20261
June 20264
July 20264
August 20265
September 20260
October 20260