Cynosurea Eclilite and Eclilite U
FDA 510(k) K050080 · Cynosure, Inc.
510(k) numberK050080
Submission
- Device name
- Cynosurea Eclilite and Eclilite U
- Applicant
- Cynosure, Inc.
Chelmsford, MA, US - Received
- January 13, 2005
- Decision date
- May 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Cynosurea Eclilite and Eclilite U cleared by the FDA?
Cynosurea Eclilite and Eclilite U (K050080) received a 510(k) decision of Substantially Equivalent on May 5, 2005, 112 days after the submission was received.
What is the product code of K050080?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.