# K032863: Ceralas D 980 Diode Laser System, Models D15, D25, D50

- Pathway: 510(k) (Traditional)
- Applicant: Biolitec, Inc.
- Decided: Mar 19, 2004 after 189 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.
155 later devices descend from it; 3 cite it directly.
0 of 156 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 Diode Laser System: named in the summary without a submission number
- (no number) CardioFocus, Inc.'s Diode Laser System used with CardioFocus, Inc.'s Surgical Lightsitic: named in the summary without a submission number

## Most influential descendants
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), 153 descendants of its own
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue).

Source page: https://510kreport.com/device/K032863
Methodology: https://510kreport.com/methodology