Cynosure Smartlipo Multiwavelength Laser With 1440NM Wavelength
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091537 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 Smartlipo Multiwavelength Laser with 1440nm wavelength is a laser device intended for surgical incision, excision, vaporization, and ablation. It is a multiwavelength laser system that includes the 1440nm wavelength as specified in its device name and specifications.
This device received FDA 510(k) clearance (K091537) under product code GEX, with a traditional clearance type and decision date of September 3, 2009. It is manufactured by Cynosure, Inc., located in Wesford, MA, and is classified for use in general and plastic surgery procedures.
Frequently asked questions
What is the Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength used for?
This laser device is intended for surgical incision, excision, vaporization, and ablation procedures, as specified in its device description and indications for use in general and plastic surgery applications.
What regulatory pathway was used for the Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength?
The device received FDA 510(k) clearance under submission number K091537, with a traditional clearance type and a decision date of September 3, 2009, based on a finding of substantial equivalence.
Who manufactures the Cynosure Smartlipo Multiwavelength Laser with 1440nm wavelength and where is it located?
The device is manufactured by Cynosure, Inc., located at 5 Carlisle Rd., Wesford, MA 01886, United States, as indicated in the manufacturer and address details provided.
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 Lutronic - Enhance your practice. Expand your services., Laser Lipo Machine | Smartlipo® Triplex® | Cynosure, Medizinische Laser | Ästhetische Lasergeräte | Cynosure Lutronic, Cynosure Smartlipo Multiwavelength Laser With 1440nm Wavelength ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091537 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, Inc.
Sources (1)
- FDA 510(k) K091537 24 fields · synced Oct 6, 2026