ATOVEN-Reusable Laser Fiber

Diotech CO

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

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

Predicate devices

2

K152667 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 K152667 as a predicate