Cleared Traditional

K172689 - DESCRIBE PFD Patch (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172689 · Merz North America, Inc. · General & Plastic Surgery device
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Nov 2017
Decision
84d
Days
Class 2
Risk

K172689 is an FDA 510(k) clearance for the DESCRIBE PFD Patch. Classified as Transparent Patch For Use In Treatment Of Tattoos (product code PKO), Class II - Special Controls.

Submitted by Merz North America, Inc. (Raleigh, US). The FDA issued a Cleared decision on November 29, 2017 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. 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 Merz North America, Inc. devices

Submission Details

510(k) Number K172689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2017
Decision Date November 29, 2017
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 114d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKO Transparent Patch For Use In Treatment Of Tattoos
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition To Reduce Formation Of Bubbles During Laser Treatment Of Tattoos.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.