Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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.
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.
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
