# K021616: Delight Dental ER: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Electro-Optics, Inc.
- Decided: Jul 11, 2002 after 56 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.
No later device cites it as a predicate yet.
0 of 1 device 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) WaterLase, Millennium dental laser system: named in the summary without a submission number

## Indications for use
Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement

Source page: https://510kreport.com/device/K021616
Methodology: https://510kreport.com/methodology