Cleared Traditional

K183485 - CryoVizion System (FDA 510(k) Clearance)

K183485 · Cryos Technologies, Inc. · Physical Medicine device
Aug 2019
Decision
254d
Days
-
Risk

K183485 is an FDA 510(k) clearance for the CryoVizion System. This device is classified as a Device, Sensing, Optical Contour.

Submitted by Cryos Technologies, Inc. (Joliette, CA). The FDA issued a Cleared decision on August 28, 2019, 254 days after receiving the submission on December 17, 2018.

This device falls under the Physical Medicine FDA review panel.

Submission Details

510(k) Number K183485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2018
Decision Date August 28, 2019
Days to Decision 254 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code LDK - Device, Sensing, Optical Contour
Device Class -