Cleared Traditional

K973572 - KELOCOTE SCAR GEL AND KELOCOTE LASER GEL

K973572 is an FDA 510(k) clearance for KELOCOTE SCAR GEL AND KELOCOTE LASER GEL, manufactured by Hanson Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K973572 · Hanson Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
32d
Days
Class 1
Risk

K973572 is an FDA 510(k) clearance for the KELOCOTE SCAR GEL AND KELOCOTE LASER GEL. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Hanson Medical, Inc. (Kingston, US). The FDA issued a Cleared decision on October 21, 1997 after a review of 32 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 Hanson Medical, Inc. devices

FDA 510(k) Submission Details - K973572

510(k) Number K973572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1997
Decision Date October 21, 1997
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 20
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K973572.
SPECTRUM DESIGNS SPECTRAGEL
K992522 · Spectrum Designs, Inc. · Oct 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968 · Smith & Nephew, Inc. · Jul 1999
CICACARE MANAGEMENT FOR SCARS
K991957 · Smith & Nephew, Inc. · Jul 1999
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · Pmt Corp. · Oct 1997
DEGANIA SILICONE SIL-K
K971482 · Degania Silicone , Ltd. · Jun 1997
SPECTRUM DESIGNS SPECTRAGEL
K970702 · Spectrum Designs, Inc. · May 1997