Cleared Traditional

K183485 - CryoVizion System

K183485 · Cryos Technologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
254d
Days
-
Risk

K183485 is an FDA 510(k) clearance for the CryoVizion System. Classified as Device, Sensing, Optical Contour (product code LDK).

Submitted by Cryos Technologies, Inc. (Joliette, CA). The FDA issued a Cleared decision on August 28, 2019 after a review of 254 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K183485

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 116d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

LDK Device Classification - Class 0,

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

Regulatory Consultant

Lok North America, Inc.
Louis-Paul Martin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 7
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K183485 · CryoVizion System
Download PDF FDA Summary Cryos Technologies, I…