Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)

Jiangxi Medex Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K243141
Device name
Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-09-30
Decision date
2024-12-26
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics.

Intended Use

Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics.

Device Description

The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswitch, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The fiber delivery systems are not included in this submission.

Summary parsed at:2026-06-01 05:29:33 UTC

Predicate devices

2

K243141 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K243141 as a predicate