VIO System (V-1000)
by Enspectra Health, Inc. 510(k)
Active
510(k) K232789
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232789 | Date22 Dec 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 10 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QZN
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4580
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent