# K964497: Ceralas Diode Laser System (Ceralas D15)

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Feb 6, 1997 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.
209 later devices descend from it; 2 cite it directly.
0 of 210 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) CeramOptec Inc.’s Ceralas Diode Laser System (Model D50): named in the summary without a submission number

## Most influential descendants
- K983058: Ceralas D Laser System, Model # Ceralas D15 (1998), 208 descendants of its own
- K991891: Ceralas Diode Laser System, Model Ceralas D15 (1999), 207 descendants of its own
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), 153 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

## Indications for use
The Ceralas Diode Laser System (“Ceralas D15”) is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat (“ENT”)), including the specific ENT procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions.

Source page: https://510kreport.com/device/K964497
Methodology: https://510kreport.com/methodology