Matrix LS-40 CO2 Laser System

Shanghai Wonderful Opto-Electrics Tech.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

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Device details

FDA 510(k) registration fields

K number
K161356
Device name
Matrix LS-40 CO2 Laser System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-05-16
Decision date
2016-09-09
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cutting
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), 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.

The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:
• Laser skin resurfacing.
• Treatment of furrows and wrinkles.
• Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
• Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
• Blepharoplasty.
• Site preparation for hair transplants.
• The fractional scanner is for 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), 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 MATRIX LS-40 CO2 Surgical laser System is a system incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch. The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.

Summary parsed at:2026-06-01 06:06:22 UTC

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