# K201109: CO2 Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Jul 15, 2020 after 79 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: 20 generations back to K943450 (1995). 357 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 363 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162169: EdgeOne CO2 Laser, Jeisys Medical, Inc. (2016) Summary page 4.
- K133895: Deka Smartxide Laser System, El.En S.P.A. (2014) Summary page 4.

## Most influential descendants
- K221597: CO2 Laser System (2022), 2 descendants of its own
- K241670: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (2024), 1 descendant of its own
- K260974: CO2 Laser Machine (Monica-I,Monica-II) (2026), 0 descendants of its own
- K250465: CO2 Laser Machine (Lume) (2025), 0 descendants of its own
- K242941: CO2 Laser Therapy Systems (SHE-LSP003-1) (2025), 0 descendants of its own

## Indications for use
The CO2 Laser Therapy System is used for body soft tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology.

Source page: https://510kreport.com/device/K201109
Methodology: https://510kreport.com/methodology