ULTRAWAVE III EX 1320
FDA 510(k) clearance K083207 · decided 2008-11-14
Clearance details
- K-number
- K083207
- Device name
- ULTRAWAVE III EX 1320
- Applicant
- Quanta System Spa
- Decision
- Substantially Equivalent
- Date received
- 2008-10-31
- Decision date
- 2008-11-14
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Solbiate Olona (Va), IT
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 recall (Z-0693-2013) | Quanta System, S.p.A. | 2013-01-17 |