LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)— 510(k) K261601
Substantially EquivalentShenzhen Chuangtong Yigou Technology Co., Ltd.
FDA 510(k) clearance K261601 for LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08), Substantially Equivalent on 2026-08-07. Applicant: Shenzhen Chuangtong Yigou Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Chuangtong Yigou Technology's LED Light Therapy Mask lists seven models: M01, M02, M03, M05, M06, M07, and M08. It's filed under product code OHS, 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, and it came in as a Traditional 510(k).
The applicant filed from Shenzhen, China. The decision came 85 calendar days after receipt (May 14 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shenzhen Chuangtong Yigou Technology 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 allMore clearances from Shenzhen Chuangtong Yigou Technology Co., 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.