Cleared Traditional

K941197 - SILK*SKIN SCAR TREATMENT

K941197 is an FDA 510(k) clearance for SILK*SKIN 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 150-day FDA review.

K941197 · Puritas Health Care, Inc. · General & Plastic Surgery device
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Aug 1994
Decision
150d
Days
Class 1
Risk

K941197 is an FDA 510(k) clearance for the SILK*SKIN 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 August 11, 1994 after a review of 150 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.

View all Puritas Health Care, Inc. devices

FDA 510(k) Submission Details - K941197

510(k) Number K941197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1994
Decision Date August 11, 1994
Days to Decision 150 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
35d slower than avg
Panel avg: 115d · This submission: 150d
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 23
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K941197.
NOVAGEL SILICONE GEL SHEETING
K963128 · Brennen Medical, Inc. · Dec 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · Brennen Medical, Inc. · May 1994
PMT SILICONE SHEETING
K935499 · Pmt Corp. · Feb 1994
CICA-CARE SILICONE GEL SHEET
K935803 · Smith & Nephew United, Inc. · Feb 1994