PORTRAIT PSR3
FDA 510(k) clearance K060948 · decided 2006-09-05
Clearance details
- K-number
- K060948
- Device name
- PORTRAIT PSR3
- Applicant
- Rhytec Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2006-04-06
- Decision date
- 2006-09-05
- Days to decision
- 152 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Reading, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portrait PSR3 System, an electro-surgical device used in dermatological applications recall (Z-0397-2007) | Rhytec Inc. | 2007-02-01 |