# K172096: Fraxis

- Pathway: 510(k) (Special)
- Applicant: Ilooda Co,., Ltd.
- Decided: Aug 9, 2017 after 29 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). 281 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 284 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160312: Fraxis Duo, Ilooda Co,., Ltd. (2016) Summary page 4.

## Most influential descendants
- K250782: Fractional CO2 Laser Machine (2025), 0 descendants of its own
- K242183: Fractional CO2 Laser Therapy System (EXFU CO2) (2024), 0 descendants of its own

## Indications for use
- C02 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

Source page: https://510kreport.com/device/K172096
Methodology: https://510kreport.com/methodology