# K071152: Palomar Erbium Handpiece

- Pathway: 510(k) (Special)
- Applicant: Palomar Medical Products, Inc.
- Decided: May 25, 2007 after 30 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: 10 generations back to K910422 (1992). 157 ancestors in all.
159 later devices descend from it; 2 cite it directly.
0 of 317 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063571: Palomar LUX2940 Handpiece, Palomar Medical Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- 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

## Indications for use
The Palomar Erbium handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: * Skin resurfacing * Treatment of wrinkles * Epidermal nevi * Telangiectasia * Spider veins * Actinic chelitis * Keloids * Verrucae * Skin tags * Anal tags * Keratoses * Scar revision (including acne scars) * Debulking benign tumors * Debulking cysts * Superficial skin lesions

Source page: https://510kreport.com/device/K071152
Methodology: https://510kreport.com/methodology