LED light therapy mask (FM-01, FM-02, FM-03)— 510(k) K223544
Substantially EquivalentGuangdong Newdermo Biotech Co., Ltd.
FDA 510(k) clearance K223544 for LED light therapy mask (FM-01, FM-02, FM-03), Substantially Equivalent on 2023-02-23. Applicant: Guangdong Newdermo Biotech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Guangdong Newdermo Biotech Co., Ltd.
- Product code
- 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
- Guangzhou, CN
Recent devices under product code OHS
view allMore clearances from Guangdong Newdermo Biotech 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 →
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