LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)— 510(k) K260150
Substantially EquivalentNOOANCE
FDA 510(k) clearance K260150 for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C), Substantially Equivalent on 2026-04-22. Applicant: NOOANCE. Device class: 2.
Summary
NOOANCE's LED FACIAL MASK is filed under product code OHS (Light Based Over The Counter Wrinkle Reduction). The name lists five models: MJ-66DB, MK-99, MK-99A, MK-99M, and MJ-66C.
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).
NOOANCE filed from Paris, France. The decision came 92 calendar days after FDA received it (January 20 to April 22, 2026).
Clearance details
- Applicant
- NOOANCE
- 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
- Paris, FR
Recent devices under product code OHS
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.