Identifiers
- 510(k) Number
- K021444 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 Photogenica Sv is a pulsed-dye laser system that utilizes organic dye as a lasing medium and emits a 585nm wavelength. It is a powered laser surgical instrument used for soft tissue application, delivering laser energy to target tissue. The device is operated via a footswitch by a clinician in a clinical setting.
The Cynosure Photogenica Sv is supplied as a complete system with dimensions of 44"x19"x24" and is used in the treatment of recurrent respiratory papillomatosis of the glottis. The device has been cleared with the FDA 510(k) number K021444 and is classified as a powered laser surgical instrument under the product code GEX, with a medical specialty in general and plastic surgery.
Frequently asked questions
What is the Cynosure Photogenica Sv used for?
The Cynosure Photogenica Sv is used for soft tissue application, specifically in the treatment of recurrent respiratory papillomatosis of the glottis.
How is the device operated?
The device is operated via a footswitch by a clinician in a clinical setting.
What are the dimensions of the Cynosure Photogenica Sv system?
The Cynosure Photogenica Sv system has dimensions of 44"x19"x24".
Is the Cynosure Photogenica Sv a single-use or reusable device?
The description does not specify if the device is single-use or reusable, but it is supplied as a complete 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 PHOTOGENICA SV (K021444) — FDA 510(k) | Innolitics, CYNOSURE PHOTOGENICA SV 510 (k) K021444 - FDA.report, PDF K021444 CYNOSURE PHOTOGENICA SV - 510kdatabase.net, PDF 510(k) Summary - 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 | K021444 | Class II | Active |
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Manufacturer
- Manufacturer
- Cynosure, Inc.
Sources (1)
- FDA 510(k) K021444 24 fields · synced Sep 27, 2026