LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)— 510(k) K230124
Substantially EquivalentLight Tree Ventures Europe B.V.
FDA 510(k) clearance K230124 for LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001), Substantially Equivalent on 2023-03-15. Applicant: Light Tree Ventures Europe B.V.. Device class: 2.
Clearance details
- Applicant
- Light Tree Ventures Europe B.V.
- 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
- Hague, NL
Recent devices under product code OHS
view allMore clearances from Light Tree Ventures Europe B.V.
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.