# K072182: Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 - Pathway: 510(k) (Traditional) - Applicant: Alma Lasers, Ltd. - Decided: Jun 27, 2008 after 326 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: 15 generations back to K943450 (1995). 273 ancestors in all. 3 later devices descend from it; 1 cites it directly. 0 of 277 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1. - K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1. - K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1. - K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 1. - K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 1. - K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1. - K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008). Cleared while this submission was under review Summary page 1. ## Most influential descendants - K101321: Ematrix CO2 (2010), 2 descendants of its own - K151655: CO2RE System (2015), 1 descendant of its own - K181523: Syneron CO2RE System (2018), 0 descendants of its own ## Indications for use The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO 2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached. The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: ยท Skin resurfacing Source page: https://510kreport.com/device/K072182 Methodology: https://510kreport.com/methodology