# K020941: Palomar Luxg Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar
- Decided: Jun 19, 2002 after 89 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
No predicates in its family tree.
1,125 later devices descend from it; 6 cite it directly.
0 of 1,126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EsteLux Standard handpiece: named in the summary without a submission number
- (no number) Lumenis (ESC) Quantum SR: named in the summary without a submission number

## Most influential descendants
- K023954: Altus Medical Coolglide Laser Systems and Accessories (2003), 1,117 descendants of its own
- K033946: Lovely System (2004), 737 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K032460: Profile BBL System (2003), 569 descendants of its own

## Indications for use
The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothennolysis of blood vessels (treatment of facial and-leg veins), and the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K020941
Methodology: https://510kreport.com/methodology