510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232789Substantially Equivalent

VIO System (V-1000)

Enspectra Health, Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232789 is the FDA 510(k) clearance record for VIO System (V-1000), a class II device, cleared for Enspectra Health, Inc. on under FDA product code QZN (Multi-Photon Imaging). FDA's definition for product code QZN reads: "To provide visible illumination of the surgical field or the patient". FDA records list one 510(k) clearance for Enspectra Health, Inc. As of , FDA records show no recalls naming K232789.

Clearance record

Decision date
Received
(102 days to decision)
Product code
QZN Multi-Photon Imaging
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Enspectra Health, Inc. 2495 Hospital Dr., Suite 300, Mountain View CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QZN

Trailing 12 months

FDA records hold no clearances under product code QZN in the trailing twelve months.

FDA records show no clearances under product code QZN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QZN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260