510(k) · Cleared
ClearedSmartlite D Frequency Doubled ND:Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 30, 2004 after an 84-day review. The FDA summary names its predicate without a number.
- Decided
- Apr 30, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Fisma Elite Family of Lasers, frequency doubled Nd:YAG Named without a submission number | |
| * | — | Fisma Dental 200 Named without a submission number | |
| * | — | Fisma Dental 300 Named without a submission number | |
| * | — | Fisma Dental 400 Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (128 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040289 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040289: Smartlite D Frequency Doubled ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040289
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026