# K162169: EdgeOne CO2 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Jeisys Medical, Inc.
- Decided: Oct 27, 2016 after 85 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: 19 generations back to K943450 (1995). 356 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 364 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100590: Edge CO2 Laser System, Jm System Co., Ltd. (2010) Summary page 4.
- K133895: Deka Smartxide Laser System, El.En S.P.A. (2014) Summary page 4.

## Most influential descendants
- K201109: CO2 Laser Therapy System (2020), 5 descendants of its own
- 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

## Indications for use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K162169
Methodology: https://510kreport.com/methodology