# K221597: CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Smedtrum Medical Technology Co., Ltd.
- Decided: Sep 15, 2022 after 105 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: 21 generations back to K943450 (1995). 358 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 361 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201109: CO2 Laser Therapy System, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 4.

## Most influential descendants
- K241670: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (2024), 1 descendant of its own
- K242941: CO2 Laser Therapy Systems (SHE-LSP003-1) (2025), 0 descendants of its own

## Indications for use
The C02 Laser System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.

Source page: https://510kreport.com/device/K221597
Methodology: https://510kreport.com/methodology