# K020835: Ceralas D10-60 810NM Diode Laser, Modelceralas Dio-60

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Jun 12, 2002 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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

## Most influential descendants
- K023624: SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 (2003), 2 descendants of its own
- K030654: Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit (2003), 1 descendant of its own
- K032805: Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit (2003), 0 descendants of its own

## Indications for use
In addition to the Ceralas D 10-60 810 nm Diode Laser System's previously-cleared indications, this device is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K020835
Methodology: https://510kreport.com/methodology