# K100270: Artisan Aesthetic System

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Mar 29, 2010 after 59 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: 14 generations back to K910422 (1992). 219 ancestors in all.
157 later devices descend from it; 5 cite it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083900: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2009) Summary page 1.
- K071768: Erbium Fractional Handpiece, Palomar Medical Products, Inc. (2007) Summary page 1.
- K090195: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2009) Summary page 1.
- K091446: Modification to LUX1540 Handpiece and Lux 1440 Handpiece, Palomar Medical Products, Inc. (2009) Summary page 1.
- K073583: Modification to Palomar LUX1540 Handpiece, Palomar Medical Products, Inc. (2008) Summary page 1.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own

## Indications for use
The Lux2940 Fractional Handpiece optics 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. The Lux2940 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 and superficial skin lesions. The Lux2940 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 dyschromnia. The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.

Source page: https://510kreport.com/device/K100270
Methodology: https://510kreport.com/methodology