# K083900: Erbium Fractional Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Feb 27, 2009 after 60 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: 13 generations back to K910422 (1992). 210 ancestors in all.
158 later devices descend from it; 2 cite it directly.
0 of 369 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071768: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K071152: Palomar Erbium Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K063571: Palomar LUX2940 Handpiece, Palomar Medical Technologies, Inc. (2007) Summary page 1.
- K080244: Palomar Lux 1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories, Reliant Technologies, Inc. (2008) Summary page 2.

## Most influential descendants
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The Erbium Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

Source page: https://510kreport.com/device/K083900
Methodology: https://510kreport.com/methodology