Manufacturer
Jeisys Medical IncorporatedEdgeOne CO2 Laser
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
- K162169
- Device name
- EdgeOne CO2 Laser
- Company
- Jeisys Medical Incorporated
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-08-03
- Decision date
- 2016-10-27
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Intended Use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Device Description
The Jeisys EdgeOne CO2 Laser is comprised of the following major components: 1. The main console unit 2. Delivery handpieces (2 surgical and one fractional) 3. Footswitch. 4. Accessories
Summary parsed at:2026-06-01 06:06:52 UTC
Predicate devices
2Cited as predicate
5CO2 Laser System
CO2 Laser Therapy System
Co2 Laser System, Models: PureLase And VanLase
Cpmt Laser (Canadian Pioneer Medical Technology Corporation)
CO2 Laser Machine (Lume)
CO2 Laser Therapy System (Model: LFS-D9U)
5 submissions cite K162169 as a predicate