# K260150: Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

- Pathway: 510(k) (Traditional)
- Applicant: Nooance
- Decided: Apr 22, 2026 after 92 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201107: Opera Lebody (Gold), Opera Lebody (Zafiro), Gtg Wellness Co., Ltd. (2020) Summary page 5.
- K241933: HIGHERDOSE Red and Infrared Light Mask (MK66-L), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 5.

## Indications for use
LED Facial Mask (Model: MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C), is intended to emit energy in the red and near-infrared spectrum for treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K260150
Methodology: https://510kreport.com/methodology