# K024088: Ceralas D 980 Laser System with Endo Laser Vein System Kit, Model: D15 and D25

- Pathway: 510(k) (Special)
- Applicant: Biolitec, Inc.
- Decided: Jan 2, 2003 after 22 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
206 later devices descend from it; 3 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ceralas D 980 nm Laser System: named in the summary without a submission number
- (no number) Ceralas D 810 nm Diode Laser System: named in the summary without a submission number

## Most influential descendants
- K040921: Cooltouch, Model NS 160 (2004), 204 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own

## Indications for use
For endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K024088
Methodology: https://510kreport.com/methodology