# K040081: Palomar Luxv Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Apr 1, 2004 after 77 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.
415 later devices descend from it; 10 cite it directly.
0 of 416 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) ClearTouch by Radiancy: named in the summary without a submission number
- (no number) Candela Smoothbeam: named in the summary without a submission number
- (no number) Laserscope Aura: named in the summary without a submission number
- (no number) ICN Photonics NLite: named in the summary without a submission number

## Most influential descendants
- K041086: Palomar Starlux Pulsed Light System (2005), 365 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own

## Indications for use
The LuxV'M handpiece is intended for the treatmt of inflammatory acne (acne vulgaris).

Source page: https://510kreport.com/device/K040081
Methodology: https://510kreport.com/methodology