# K060069: Palomar Luxir Fractional Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Mar 2, 2006 after 52 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: 2 generations back to K842810 (1984). 8 ancestors in all.
107 later devices descend from it; 2 cite 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)
- K990850: Coopersurgical Coagulator for Tattoo Removal, CooperSurgical, Inc. (1999) Summary page 1.
- K974168: Coopersurgical Infrared Coagulator, Hogan & Hartson (1998) Summary page 1.
- K911648: Redfield Infrared Coagulator, Redfield Corp. (1991) Summary page 1.

## Most influential descendants
- K070298: Modification to Palomar Luxir Handpiece (2007), 64 descendants of its own
- K110907: Palomar Icon (TM) Aesthetic System (2011), 57 descendants of its own
- K111303: Dermatological Treatment Device Family (2011), 56 descendants of its own
- K130028: Resurfx 1565NM Laser Module (2013), 41 descendants of its own
- K142860: Lumenis M22 System (2015), 38 descendants of its own

## Indications for use
The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.

Source page: https://510kreport.com/device/K060069
Methodology: https://510kreport.com/methodology