Manufacturer
Wuhan Gigaa Optronics Technology Co., Ltd.MEDICAL DIODE LASER SYSTEMS
Wuhan Gigaa Optronics Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
2Cited as predicate
3Medical Diode Laser Systems
Medical diode laser systems (CHARISMA, REGAL)
Veincare
3 submissions cite K160549 as a predicate