myLEDmask 2 (MJ-144)— 510(k) K260415
Substantially EquivalentLight Tree Ventures Europe B.V.
FDA 510(k) clearance K260415 for myLEDmask 2 (MJ-144), Substantially Equivalent on 2026-05-12. Applicant: Light Tree Ventures Europe B.V.. Device class: 2.
Summary
Light Tree Ventures Europe's myLEDmask 2 (MJ-144) is filed under 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 the submission was a Traditional 510(k).
Light Tree Ventures filed from Den Haag, Netherlands. Review took 92 calendar days (February 9 to May 12, 2026).
Clearance details
- Applicant
- Light Tree Ventures Europe B.V.
- 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
- Den Haag, 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.