# K232795: Led Mask Platinum Exclusive MD

- Pathway: 510(k) (Traditional)
- Applicant: Stg24 Co., Ltd.
- Decided: Dec 7, 2023 after 86 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: 16 generations back to K943450 (1995). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190443: MMSphere, Galactic Beauty, LLC (2019) Summary page 5.
- K222377: Led Mask Platinum Md, Cellreturn Co., Ltd. (2022) Summary page 6.

## Indications for use
LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face.

Source page: https://510kreport.com/device/K232795
Methodology: https://510kreport.com/methodology