Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
- 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.
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.
The Ilooda Fraxis CO2 Laser is comprised of the following major components: 1. The main console unit 2. Delivery handpieces (2) 3. Footswitch. 4. Accessories. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
Summary parsed at:2026-06-01 06:00:34 UTC
