SMARTXIDE
FDA 510(k) clearance K031224 · decided 2003-05-09
Clearance details
- K-number
- K031224
- Device name
- SMARTXIDE
- Applicant
- Cynosure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-17
- Decision date
- 2003-05-09
- Days to decision
- 22 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
- Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.