Cleared Traditional

CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (K172203) - FDA 510(k) Clearance

K172203 · Nuance Medical, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
89d
Days
-
Risk

K172203 is an FDA 510(k) clearance for the CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray. Classified as Vapocoolant Device (product code MLY).

Submitted by Nuance Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuance Medical, LLC devices

Submission Details

510(k) Number K172203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2017
Decision Date October 18, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MLY Vapocoolant Device
Device Class -

Regulatory Peers - MLY Vapocoolant Device

All 8
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