# K030700: Ceralas D 10-60 810NM Laser System with Endo Laser Vein System Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Jun 4, 2003 after 90 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.
205 later devices descend from it; 1 cites it directly.
0 of 206 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) Diomed 810nm Surgical Laser: named in the summary without a submission number
- (no number) Biolitec Ceralas D10-60 810nm Diode Laser: named in the summary without a submission number
- (no number) Biolitec Ceralas D 980 nm Diode Laser: 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
Indicated for use in treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein.

Source page: https://510kreport.com/device/K030700
Methodology: https://510kreport.com/methodology