B.Light Clear Evo and B.Light Restore Evo— 510(k) K223919
Substantially EquivalentBemer Int AG
FDA 510(k) clearance K223919 for B.Light Clear Evo and B.Light Restore Evo, Substantially Equivalent on 2023-09-23. Applicant: Bemer Int AG. Device class: 2.
Clearance details
- Applicant
- Bemer Int AG
- 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
- Triesen, LI
Recent devices under product code OHS
view allMore clearances from Bemer Int AG
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.