# K143713: Lustre PRO Light System

- Pathway: 510(k) (Traditional)
- Applicant: Ambicare Health, Ltd.
- Decided: Jan 19, 2016 after 386 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 11 generations back to K943450 (1995). 97 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 5.

## Most influential descendants
- K231555: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (2023), 1 descendant of its own
- K252994: LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) (2025), 0 descendants of its own

## Indications for use
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K143713
Methodology: https://510kreport.com/methodology