Manufacturer
Ilooda Co,., Ltd.Fraxis
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K172096
- Device name
- Fraxis
- Company
- Ilooda Co,., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-07-11
- Decision date
- 2017-08-09
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
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.
Intended Use
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.
Device Description
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
Predicate devices
1FRAXIS DUO
K172096 references 1 predicate/reference device
Cited as predicate
3AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Fractional CO2 Laser Therapy System (EXFU CO2)
Fractional CO2 Laser Machine
3 submissions cite K172096 as a predicate