# K031125: Cynosure Smart File ND:Yag Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Oct 9, 2003 after 183 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) Millennium PerioLase: named in the summary without a submission number
- (no number) Lares Research SunLase 800P: named in the summary without a submission number

## Indications for use
The Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.

Source page: https://510kreport.com/device/K031125
Methodology: https://510kreport.com/methodology