Manufacturer
Ami, Inc.Fractional CO2 Surgical Laser System
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K173359
- Device name
- Fractional CO2 Surgical Laser System
- Company
- Ami, Inc.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-10-26
- Decision date
- 2018-07-05
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
Intended Use
The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
Device Description
The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry. This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch.
Summary parsed at:2026-06-01 05:56:33 UTC