Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more— 510(k) K260767
Substantially EquivalentKam Yuen Plastic Products , Ltd.
FDA 510(k) clearance K260767 for Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more, Substantially Equivalent on 2026-08-31. Applicant: Kam Yuen Plastic Products , Ltd.. Device class: 2.
Summary
Kam Yuen Plastic Products filed Facial Beauty Device, which covers three models: the Facial Mask LED Beauty Device A-901, the Facial LED & EMS Beauty Device A-902, and the Facial Mask LED & EMS Beauty Device A-907. Product code OHS is light based over-the-counter wrinkle reduction.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
The company filed from Zhongshan, China. The decision came 175 calendar days after receipt (March 9 to August 31, 2026), and it was substantially equivalent.
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
- Product code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhongshan, CN
Recent devices under product code OHS
view all- K262984 — Red & Near Infrared LED Light Phototherapy Face Mask (Bway-FM01, Bway-FM02, Bway-FM03, Bway-FM05, Bway-FM06, Bway-FN01, Bway-E01, Bway-E02)
- K262752 — Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
- K262932 — AMIRO Spectra 10-in-1 LED Light Therapy Mask (L3)
- K261602 — Eye Recovery Pro (PH-e03)
- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
More clearances from Kam Yuen Plastic Products , Ltd.
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.