Cleared Traditional

SNA-001 Silver Photoparticle Topical Gel (K192620) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K192620 · Sienna Biopharmaceuticals, Inc. · General & Plastic Surgery device
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Aug 2020
Decision
324d
Days
Class 2
Risk

K192620 is an FDA 510(k) clearance for the SNA-001 Silver Photoparticle Topical Gel. Classified as Laser Absorbing Particles (product code QCY), Class II - Special Controls.

Submitted by Sienna Biopharmaceuticals, Inc. (Westlake Village, US). The FDA issued a Cleared decision on August 12, 2020 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sienna Biopharmaceuticals, Inc. devices

Submission Details

510(k) Number K192620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2019
Decision Date August 12, 2020
Days to Decision 324 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 115d · This submission: 324d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QCY Laser Absorbing Particles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Particles Are Applied To The Target Tissue(s) For The Purpose Of Absorbing Laser/light Energy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.