# K040289: Smartlite D Frequency Doubled ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Apr 30, 2004 after 84 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) Fisma Elite Family of Lasers, frequency doubled Nd:YAG: named in the summary without a submission number
- (no number) Fisma Dental 200: named in the summary without a submission number
- (no number) Fisma Dental 300: named in the summary without a submission number
- (no number) Fisma Dental 400: named in the summary without a submission number

## Indications for use
The SmartLite D laser device is intended for ablation, incision, excision, vaporization and coagulation of soft tissue, in ophthalmology, ENT, and dermatology. In addition, the laser is intended for application in dentistry including: * Frenectomy * Treatment of Oral Mucous Cysts * Treatment of Benign Vascular Lesions * Photocoagulation of Superficial Vessels * Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels * Treatment of Superficial Tongue Lesions * Tissue Management and Hemostasis for Crown and Bridge Impressions * Incision and Drainage for Abscess * Gingivoplasty / Gingivectomy * Hemostasis during Dental Procedures * Operculectomy (Operculotomy) * Excisional Biopsy * Free Gingival Graft (Adjunct) * Vestibuloplasty * Soft Gutta Percha * Treatment of Canker sores, Herpetic Lesions, and Aphthous Ulcers * Laser-assisted Bleaching / Whitening of the Teeth

Source page: https://510kreport.com/device/K040289
Methodology: https://510kreport.com/methodology