LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)— 510(k) K254007
Substantially EquivalentSZ KKS Silicone&Electronic Co., Ltd.
FDA 510(k) clearance K254007 for LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281), Substantially Equivalent on 2026-02-12. Applicant: SZ KKS Silicone&Electronic Co., Ltd.. Device class: 2.
Summary
SZ KKS Silicone&Electronic's LED Light Therapy Silicone Face Mask lists three models: kks-225, kks-280, and kks-281. It's filed under product code OHS (Light Based Over The Counter Wrinkle Reduction), and the record doesn't say how they differ.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
SZ KKS Silicone&Electronic filed from Shenzhen, China. The decision came 59 calendar days after FDA received it (December 15, 2025 to February 12, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- SZ KKS Silicone&Electronic Co., 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
- Shenzhen, CN
Recent devices under product code OHS
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.