510(k) K123407
- Device
- CELLULAZE LASER
- Applicant
- CYNOSURE, INC.
- 510(k) number
- K123407
- Product code
- OYW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-29
- Date received
- 2012-11-05
- Regulation
- 878.4810
- Classification name
- Laser, Cellulite Appearance
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- IRINA KULINETS
- Address
- 5 Carlisle Rd. Wesford MA US 01886 01886
FDA Registration Numbers#
- 1222773
- 1222993
- 1221275
- 3015452693
- 3043657394
- 3001431138
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OYW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102541 | CYNOSURE CELLULAZE LASER | Cynosure, Inc. | 2012-01-26 |
Legacy Summary#
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FDA Review#
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