# K993002: Ceralas D 980NM Diode Laser System, Model D15

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Oct 14, 1999 after 37 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.
179 later devices descend from it; 3 cite it directly.
0 of 180 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) American Dental Technologies Plasma Arc Curing System: 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
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
Intended for light activation of bleaching materials for teeth whiteniag. Note: This is an addirional indication to the already cleared indications for use.

Source page: https://510kreport.com/device/K993002
Methodology: https://510kreport.com/methodology