Manufacturer
Nanjing Bestview Laser S&T Co., Ltd.CO2 Laser Machine (Lume)
Nanjing Bestview Laser S&T Co., Ltd.
Country / Region:China (CN)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
- K250465
- Device name
- CO2 Laser Machine (Lume)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-02-18
- Decision date
- 2025-06-09
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The CO2 Laser Machine is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology. 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), gynecology, 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
The CO2 Laser Machine is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology. 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), gynecology, 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 CO2 Laser Machine generates a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).
Summary parsed at:2026-06-01 05:22:25 UTC
Predicate devices
2EdgeOne CO2 Laser
CO2 Laser Therapy System
K250465 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250465 as a predicate
