MEDICAL DIODE LASER SYSTEMS

Wuhan Gigaa Optronics Technology 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

3

Device details

FDA 510(k) registration fields

K number
K160549
Device name
MEDICAL DIODE LASER SYSTEMS
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2016-02-29
Decision date
2017-04-07
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Vascular treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

The "VELASIL-15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Intended Use

The "VELASIL-15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

Device Description

Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELASⅡ-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

Summary parsed at:2026-06-01 05:58:39 UTC

Predicate devices

2

K160549 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K160549 as a predicate