CO2 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

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

2

K242941 references 2 predicate/reference devices

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0

No later 510(k)s cite this device yet

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