# K160312: Fraxis Duo

- Pathway: 510(k) (Traditional)
- Applicant: Ilooda Co,., Ltd.
- Decided: Oct 28, 2016 after 266 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: 18 generations back to K943450 (1995). 280 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123573: Youlaser CO2 Laser, Quanta System Spa (2013) Summary page 5.
- K130501: Intensif, Endymed Medical, Ltd. (2014) Summary page 5.

## Most influential descendants
- K170325: Secret RF (2017), 10 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own
- K180654: PINXEL-RF system (2018), 3 descendants of its own
- K172096: Fraxis (2017), 2 descendants of its own
- K233123: Silkro (2024), 1 descendant of its own

## Indications for use
- CO2 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. - HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Source page: https://510kreport.com/device/K160312
Methodology: https://510kreport.com/methodology