# K242068: LED Light Therapy Mask (RT01)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Dechang Electrical Machinery Made Co.,Ltd
- Decided: Apr 4, 2025 after 263 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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: 16 generations back to K943450 (1995). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0, Mz Skin (2021) Summary page 6.

## Indications for use
The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask is an over-the-counter device intended to emit energy in the red and Near Infrared spectrum and is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K242068
Methodology: https://510kreport.com/methodology