# K992013: DEL2940 Dental Erbium Laser, Delite Dental Erbium Laser

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Sep 8, 1999 after 85 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.
242 later devices descend from it; 1 cites it directly.
0 of 243 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) Centauri Er:YAG Dental Laser System, Premier Laser Systems, Inc.: named in the summary without a submission number

## Most influential descendants
- K012127: Pulsemaster Erbium Dental Laser System (2001), 241 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Indications for use
For Removal of Caries and for Cavity Preparation in Primary and Secondary Teeth.

Source page: https://510kreport.com/device/K992013
Methodology: https://510kreport.com/methodology