# K213184: MZ Skin LightMAX Supercharged LED Mask 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Mz Skin
- Decided: Nov 23, 2021 after 55 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: 15 generations back to K943450 (1995). 112 ancestors in all.
35 later devices descend from it; 4 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210948: Omnilux CLEAR, Globalmed Technologies (2021) Summary page 6.
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 6.

## Most influential descendants
- K214103: Shani Darden LED light therapy mask (2022), 19 descendants of its own
- K230293: TheraFace Mask (2023), 16 descendants of its own
- K230124: LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) (2023), 10 descendants of its own
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023) (2023), 9 descendants of its own
- K221775: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (2022), 7 descendants of its own

## Indications for use
The MZ Skin LightMAX Supercharged LED Mask 2.0 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 MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K213184
Methodology: https://510kreport.com/methodology