# K071768: Erbium Fractional Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Nov 5, 2007 after 129 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.
162 later devices descend from it; 5 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073583: Modification to Palomar LUX1540 Handpiece (2008), 159 descendants of its own
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece (2009), 158 descendants of its own
- K083900: Erbium Fractional Handpiece (2009), 158 descendants of its own
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own

## Indications for use
Dermatological procedures requiring the coagulation of soft tissue; Skin resurfacing procedures.

Source page: https://510kreport.com/device/K071768
Methodology: https://510kreport.com/methodology