Manufacturer
Beijing Sano Laser S&T Development Co.,LtdCO2 Laser Therapy Systems (SHE-LSP003-1)
Beijing Sano Laser S&T Development 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
- K242941
- Device name
- CO2 Laser Therapy Systems (SHE-LSP003-1)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-09-25
- Decision date
- 2025-01-27
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Intended Use
The CO2 Laser Therapy Systems is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Device Description
CO2 Laser Therapy Systems is monochromatic light with strong penetration and precise focusing; When a continuous laser beam with a certain energy irradiates biological tissue, the instantaneous high temperature causes photo induced solidification and photo induced vaporization to irradiated tissue. With modulation pulse mode of CO2 laser, treatment effect can be achieved by control of laser emission frequency. After choosing laser Power, despite the frequency of laser emission, the laser is continuously output at a fixed Interval Time of 1 ms. Changes in frequency doesn't affect interval time.
Summary parsed at:2026-06-01 05:21:19 UTC
Predicate devices
2CO2 Laser Therapy Machine
Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
K242941 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 K242941 as a predicate