Product code QZN— General, Plastic Surgery

VIO System (V-1000)

Classification name: Multi-Photon Imaging
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Total cleared: 1
First cleared: 2023-12-22
Most recent: 2023-12-22

FDA classification definition

“To provide visible illumination of the surgical field or the patient”
— U.S. Food and Drug Administration, device classification record for product code QZN under 21 CFR 878.4580, via openFDA

Market context for product code QZN

FDA has cleared 1 device under product code QZN, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QZN

Enspectra Health, Inc.1 clearance

Recent clearances under product code QZN

K232789 — VIO System (V-1000)Enspectra Health, Inc.·2023-12-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.