# K031389: Cynosure Smart 2940D ER:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Oct 1, 2003 after 152 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) Fotona Fidelis: named in the summary without a submission number
- (no number) American Dental Technologies Pulsemaster Er:YAG: named in the summary without a submission number

## Indications for use
The Smart 2940D Er:YAG Laser system is indicated to be used for ablation, incision, excision, vaporization and coagulation of hard and soft intraoral tissue. The procedures include caries removal, cavity preparation and enainal etching.

Source page: https://510kreport.com/device/K031389
Methodology: https://510kreport.com/methodology