Cynosure Smart File Nd:YAG Lasers
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031125 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cynosure Smart File Nd:YAG Lasers is a powered laser surgical instrument that utilizes a Nd:YAG crystal rod as the lasing medium to deliver laser energy at a wavelength of 1,064 nm via a contact fiber optic delivery system. It is designed to perform soft tissue ablation, incision, excision, coagulation, and vaporization, with activation controlled by a footswitch.
The device is intended for use in clinical settings, including general and plastic surgery environments. It is supplied as a reusable system and has received FDA 510(k) clearance under product code GEX, with decision date October 9, 2003, and is classified as substantially equivalent to a predicate device.
Frequently asked questions
What is the Cynosure Smart File Nd:YAG Lasers used for?
It is designed to perform soft tissue ablation, incision, excision, coagulation, and vaporization, with activation controlled by a footswitch, and is intended for use in clinical settings including general and plastic surgery environments.
How is the Cynosure Smart File Nd:YAG Lasers supplied and is it reusable?
The device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and sterilization between procedures, as indicated in the device description.
What wavelength and delivery method does the Cynosure Smart File Nd:YAG Lasers use?
It utilizes a Nd:YAG crystal rod as the lasing medium to deliver laser energy at a wavelength of 1,064 nm via a contact fiber optic delivery system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CYNOSURE SMART FILE ND:YAG LASERS - Innolitics, PDF K031125 CYNOSURE SMART FILE ND:YAG LASERS - 510kdatabase.net, CYNOSURE SMART FILE ND:YAG LASERS 510(k) K031125 - FDA.report, PDF 510(K) Summarv - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031125 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, Inc.
Sources (1)
- FDA 510(k) K031125 24 fields · synced Sep 27, 2026