# K032864: Ceralas D 810 Diode Laser System, Model D15

- 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.
306 later devices descend from it; 4 cite it directly.
0 of 307 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 810 Diode Laser System: named in the summary without a submission 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 Lightstic: named in the summary without a submission number

## Most influential descendants
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene (2006), 299 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K071295: 100W Ceralas D 980NM Diode Laser (2007), 230 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
The Ceralas D 810 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 810 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 810 is specifically indicated for hemostasis or coagulation of soft tissue (including cardiac tissue).

Source page: https://510kreport.com/device/K032864
Methodology: https://510kreport.com/methodology