# K231555: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))

- Pathway: 510(k) (Traditional)
- Applicant: iSMART Developments, Ltd.
- Decided: Jul 27, 2023 after 58 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). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 116 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.
- K143713: Lustre PRO Light System, Ambicare Health, Ltd. (2016) Summary page 6.

## Most influential descendants
- K252994: LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (2025), 0 descendants of its own

## Indications for use
The LUMA LED light patches are over-the-counter devices intended to emit energy in the visible and near infra-red light spectrum. LUMA Blemish 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. LUMA Revive 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 facial wrinkles.

Source page: https://510kreport.com/device/K231555
Methodology: https://510kreport.com/methodology