ELITE MPX LASER SYSTEM WITH CRYO C
FDA 510(k) clearance K091169 · decided 2009-05-13
Clearance details
- K-number
- K091169
- Device name
- ELITE MPX LASER SYSTEM WITH CRYO C
- Applicant
- Cynosure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-22
- Decision date
- 2009-05-13
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Wesford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System recall (Z-0169-2015) | Cynosure, Inc. | 2014-11-04 |