VIO System (V-1000)
FDA 510(k) clearance K232789 · decided 2023-12-22
Clearance details
- K-number
- K232789
- Device name
- VIO System (V-1000)
- Applicant
- Enspectra Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-11
- Decision date
- 2023-12-22
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- QZN
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.