Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more— 510(k) K260767

Clearance details

Device name as filed

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)

Applicant

Kam Yuen Plastic Products , Ltd.

Product code

Code OHS

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2026-03-09

Decision date

2026-08-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Zhongshan, CN

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Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →