# K991891: Ceralas Diode Laser System, Model Ceralas D15

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Jun 24, 1999 after 21 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
Longest line of descent: 3 generations back to K922901 (1992). 9 ancestors in all.
207 later devices descend from it; 5 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983058: Ceralas D Laser System, Model # Ceralas D15, Ceram Optec, Inc. (1998) Summary page 1.
- (no number) Premier Laser System Pegasus Nd:YAG Laser: 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
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K053161: Sirolaser (2006), 79 descendants of its own
- K062258: Genesis Diode Laser (2007), 71 descendants of its own

## Indications for use
Pulpotomy Pulpotomy as an adjunct to root canal therapy

Source page: https://510kreport.com/device/K991891
Methodology: https://510kreport.com/methodology