Cleared Traditional

K953420 - SILK*SKIN SCAR TREATMENT

K953420 is an FDA 510(k) clearance for SILK*SKIN SCAR TREATMENT, manufactured by Silk*Skin Care Co.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K953420 · Silk*Skin Care Co. · General & Plastic Surgery device
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Sep 1995
Decision
78d
Days
Class 1
Risk

K953420 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 Silk*Skin Care Co. (Queensbury, US). The FDA issued a Cleared decision on September 26, 1995 after a review of 78 days - a notably fast clearance 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: 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 Silk*Skin Care Co. devices

FDA 510(k) Submission Details - K953420

510(k) Number K953420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date September 26, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
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 60
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K953420.
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013 · Mentor Corp. · Aug 1996
SILGEL TOPICAL GEL SHEET
K960254 · Rofil Medical USA, Inc. · Apr 1996
STERILIZED TRI BLOCK POLYMER GEL SHEET
K955664 · Silipos, Inc. · Feb 1996
SKIN NEUVEAU SCAR TREATMENT
K942339 · Puritas Health Care, Inc. · Nov 1994
SILK*SKIN SCAR TREATMENT
K941197 · Puritas Health Care, Inc. · Aug 1994
NOVAGEL SILICONE GEL SHEETING
K941125 · Brennen Medical, Inc. · May 1994