510(k) K232789
- Device
- VIO System (V-1000)
- Applicant
- Enspectra Health, Inc.
- 510(k) number
- K232789
- Product code
- QZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-22
- Date received
- 2023-09-11
- Regulation
- 878.4580
- Classification name
- Multi-Photon Imaging
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Grace Li
- Address
- 2495 Hospital Dr., Suite 300 Mountain View CA US 94040 94040