Manufacturer
Diotech COATOVEN-Reusable Laser Fiber
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K152667
- Device name
- ATOVEN-Reusable Laser Fiber
- Company
- Diotech CO
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-09-17
- Decision date
- 2016-06-09
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
Intended Use
ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
Device Description
ATOVEN-Reusable Laser Fiber is a free-beam delivery device that transits laser energy into intended direction. Fiber length is 2.9 meters. This device can be connected with SMA905 connector and deliver to 810~1470 nm. This device can be connected with cleared surgical use laser diode.
Summary parsed at:2026-06-01 06:05:11 UTC