Cleared Traditional

K942339 - SKIN NEUVEAU SCAR TREATMENT

K942339 is an FDA 510(k) clearance for SKIN NEUVEAU SCAR TREATMENT, manufactured by Puritas Health Care, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K942339 · Puritas Health Care, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
196d
Days
Class 1
Risk

K942339 is an FDA 510(k) clearance for the SKIN NEUVEAU SCAR TREATMENT. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 196 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - 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. Standard predicate reliance. 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.

FDA 510(k) Submission Details - K942339

510(k) Number K942339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1994
Decision Date November 28, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 78
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K942339.
SILON SILICONE TEXTILE COMPOSITE
K952546 · Bio Med Sciences, Inc. · Aug 1995
SILON SILICONE FOAM SHEETING
K946362 · Bio Med Sciences, Inc. · Jul 1995
SILON(R) SILICONE THERMOPLASTIC SHEETING
K945892 · Bio Med Sciences, Inc. · Mar 1995
TRI BLOCK POLUMER GEL SHEETING
K942695 · Silipos, Inc. · Nov 1994
SILK*SKIN SCAR TREATMENT
K941197 · Puritas Health Care, Inc. · Aug 1994
EPI-DERM SILICONE GEL SHEETING
K942156 · Biodermis Corp. · Jun 1994
K942339 · SKIN NEUVEAU SCAR TREATMENT
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