Manufacturer
Ilooda Co,., Ltd.FRAXIS DUO
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K160312
- Device name
- FRAXIS DUO
- 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
- 2016-02-05
- Decision date
- 2016-10-28
- Submission type
- Traditional
- 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. - CO2 LASER PART YOULASER CO2 laser when used in traditional, non-fractionated 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. YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing. - HF electrosurgical Part: The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Intended 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.
Device Description
The FRAXIS DUO is a surgical instrument that combines CO2 laser and high-frequency electrosurgical capabilities. The CO2 laser part features a fractional mode for ablative skin resurfacing and a non-fractional mode for various surgical applications. The device includes an articulated arm with a scanner and normal handpieces for laser delivery, and a bipolar handpiece for the electrosurgical part. It operates with a color touch panel interface and has specific electrical requirements.
Summary parsed at:2026-06-01 06:05:48 UTC
Predicate devices
2Cited as predicate
2Fraxis
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
2 submissions cite K160312 as a predicate
