510(k) K102541
- Device
- CYNOSURE CELLULAZE LASER
- Applicant
- CYNOSURE, INC.
- 510(k) number
- K102541
- Product code
- OYW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-01-26
- Date received
- 2010-09-03
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE CHO
- Address
- 5 Carlisle Rd. Wesford MA US 01886 01886
FDA Registration Numbers#
- 1222773
- 1222993
- 1221275
- 3015452693
- 3043657394
- 3001431138
Source Documents#
Other 510(k) Records For Product Code OYW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123407 | CELLULAZE LASER | Cynosure, Inc. | 2013-03-29 |
Legacy Summary#
summary
FDA Review#
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