Product Code: MDA FDA class 1 21 CFR 878.4025

Elastomer, Silicone, For Scar Management

General, Plastic Surgery

The silicone elastomer for scar management is a general and plastic surgery device applied topically over healing or mature scars to flatten, soften, and reduce discoloration, commonly used for hypertrophic or keloid scars. It is classified as FDA Class I under 21 CFR 878.4025 within the General and Plastic Surgery specialty and is GMP-exempt, meaning it is not subject to full quality system regulation requirements. The product code is MDA and the device is not implanted. It does not sustain life.

View on FDA

510(k)s

FEI Numbers

190

Registration Numbers

190

Unique Applicants

Years Active

Basic Information

Product Code: MDA
Device Class: FDA class 1
Regulation Number: 878.4025
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 81 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K112131	NEODYNE DRESSING	Sep 29, 2011	Substantially Equivalent	Neodyne Biosciences, Inc.
K111733	CORELEADER SCAR-DIMMER	Sep 22, 2011	Substantially Equivalent	Coreleader Biotech Co., Ltd.
K083718	BEAU RX SCAR CARE GEL	Jan 26, 2009	Substantially Equivalent	Beau RX Solutions, LLC
K053481	KELO-COTE SPRAY	Apr 14, 2006	Substantially Equivalent	Advanced Bio-Technologies, Inc.
K041704	NEWGEL AND NEWGEL PLUS E	Oct 17, 2005	Substantially Equivalent	Newmedical Technology, Inc.
K040307	HANSON SCAR ADE	Aug 12, 2004	Substantially Equivalent	Hanson Medical, Inc.
K024057	CURAD SCAR THERAPY	Jun 18, 2003	Substantially Equivalent	Beiersdorf, Inc.
K024160	NEOSPORIN SCAR SOLUTION	Mar 17, 2003	Substantially Equivalent	Warner-Lambert Co.
K023678	DIMISIL SCAR GEL	Jan 23, 2003	Substantially Equivalent	Aesthetic and Reconstructive Technologies, Inc.
K023136	OLEEVA FABRIC	Oct 16, 2002	Substantially Equivalent	Bio Med Sciences, Inc.
K014036	MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.	Feb 14, 2002	Substantially Equivalent	Medtrade Products , Ltd.
K013732	GELZONE	Feb 07, 2002	Substantially Equivalent	Implantech Associates, Inc.
K012419	CONFORM SHEETING, MODEL IGEL	Oct 24, 2001	Substantially Equivalent	Implantech Associates, Inc.
K010675	ENSIL FABRIC	May 30, 2001	Substantially Equivalent	Gottfried Medical, Inc.
K010245	ACTIVHEAL SCAR MANAGEMENT DRESSING	Apr 25, 2001	Substantially Equivalent	Advanced Medical Solutions, Ltd.
K003979	MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD	Mar 19, 2001	Substantially Equivalent	Medtrade Products , Ltd.
K003948	EPI-DERM SILICONE GEL SHEETING	Jan 29, 2001	Substantially Equivalent	Biodermis Corp.
K002488	KELO-COTE TOPICAL GEL	Jan 05, 2001	Substantially Equivalent	Advanced Bio-Technologies, Inc.
K002109	OLEEVA FOAM	Aug 31, 2000	Substantially Equivalent	Bio Med Sciences, Inc.
K001608	BLAINE SCARCARE PATCH	Jul 25, 2000	Substantially Equivalent	Blaine Labs, Inc.
K992522	SPECTRUM DESIGNS SPECTRAGEL	Oct 26, 1999	Substantially Equivalent	Spectrum Designs, Inc.
K991970	SCAREASE SHEETS & SCAREASE GEL	Oct 25, 1999	Substantially Equivalent	Pillar Surgical
K991312	SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING	Aug 20, 1999	Substantially Equivalent	Library Medical, Inc.
K990651	SKIN 2 FORTE SILICONE SHEETING	Aug 13, 1999	Substantially Equivalent	United Hospital Technologies, Inc.
K984029	SILGEL STC-S	Aug 05, 1999	Substantially Equivalent	Nagor , Ltd.
K992146	SCARAID SILICONE GEL SHEETING	Jul 30, 1999	Substantially Equivalent	Biodermis Corp.
K991968	CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.	Jul 30, 1999	Substantially Equivalent	Smith & Nephew, Inc.
K991957	CICACARE MANAGEMENT FOR SCARS	Jul 20, 1999	Substantially Equivalent	Smith & Nephew, Inc.
K991478	TENDER TOUCH SILICONE GEL PADS	Jun 21, 1999	Substantially Equivalent	Capital Marketing Technologies, Inc.
K991630	ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET	Jun 11, 1999	Substantially Equivalent	Advanced Medical Solutions Group Plc
K991604	EPI-FOAM SILICONE SHEETING	Jun 09, 1999	Substantially Equivalent	Biodermis Corp.
K981353	AVOGEL	Jun 01, 1999	Substantially Equivalent	Avocet Polymer Technologies, Inc.
K984213	NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS	Apr 14, 1999	Substantially Equivalent	Capital Marketing Technologies, Inc.
K984115	SCAREASE & SCAREASE ADHESIVE GEL	Feb 12, 1999	Substantially Equivalent	Scarease, Inc.
K982036	SILON SCAR STRIPS	Aug 06, 1998	Substantially Equivalent	Bio Med Sciences, Inc.
K982051	KELOCATE SHEETING	Aug 05, 1998	Substantially Equivalent	Allied Biomedical Corp.
K981902	SPENCO SILICONE GEL SHEET	Jun 25, 1998	Substantially Equivalent	Spenco Medical Corp.
K981387	EVANESCE SCAR MANAGEMENT SYSTEM	Jun 10, 1998	Substantially Equivalent	Medical Scientific, Inc.
K980563	SKAR-KARE SHEET	May 20, 1998	Substantially Equivalent	Life Medical Sciences, Inc.
K974380	REJUVENESS	Apr 03, 1998	Substantially Equivalent	Rejuveness Pharamceuticals, Inc.
K974172	SILGEL TOPICAL GEL SHEET	Mar 30, 1998	Substantially Equivalent	Nagor , Ltd.
K974143	KMC NEWSKIN	Mar 27, 1998	Substantially Equivalent	Kmc Intl. Co.
K974354	MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE	Mar 05, 1998	Substantially Equivalent	Sca Molnlycke
K973271	SKAR-KARE	Nov 19, 1997	Substantially Equivalent	Target Health, Inc.
K973572	KELOCOTE SCAR GEL AND KELOCOTE LASER GEL	Oct 21, 1997	Substantially Equivalent	Hanson Medical, Inc.
K972597	PMT NEW BEGINNINGS GELSHAPES & AMEND	Oct 01, 1997	Substantially Equivalent	Pmt Corp.
K971916	MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL	Jul 29, 1997	Substantially Equivalent	Medical Z, S.A.
K971009	SCAR CARE	Jul 29, 1997	Substantially Equivalent	Target Health, Inc.
K971482	DEGANIA SILICONE SIL-K	Jun 24, 1997	Substantially Equivalent	Degania Silicone , Ltd.
K971468	SCAR HEAL	Jun 10, 1997	Substantially Equivalent	Specialty Systems, Inc.
K970702	SPECTRUM DESIGNS SPECTRAGEL	May 12, 1997	Substantially Equivalent	Spectrum Designs, Inc.
K964846	IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING	Feb 12, 1997	Substantially Equivalent	Implantech Associates, Inc.
K963128	NOVAGEL SILICONE GEL SHEETING	Dec 05, 1996	Substantially Equivalent	Brennen Medical, Inc.
K961410	DURASIL (MODIFICATION)	Sep 03, 1996	Substantially Equivalent	The S. F. Group, Inc.
K962013	MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT	Aug 22, 1996	Substantially Equivalent	Mentor Corp.
K960254	SILGEL TOPICAL GEL SHEET	Apr 02, 1996	Substantially Equivalent	Rofil Medical USA, Inc.
K955664	STERILIZED TRI BLOCK POLYMER GEL SHEET	Feb 28, 1996	Substantially Equivalent	Silipos, Inc.
K954413	KELOCOTE	Nov 29, 1995	Substantially Equivalent	Allied Biomedical Corp.
K952612	DURASIL	Nov 22, 1995	Substantially Equivalent	The S. F. Group, Inc.
K953420	SILK*SKIN SCAR TREATMENT	Sep 26, 1995	Substantially Equivalent	Silk*Skin Care Co.
K952546	SILON SILICONE TEXTILE COMPOSITE	Aug 07, 1995	Substantially Equivalent	Bio Med Sciences, Inc.
K946362	SILON SILICONE FOAM SHEETING	Jul 13, 1995	Substantially Equivalent	Bio Med Sciences, Inc.
K945892	SILON(R) SILICONE THERMOPLASTIC SHEETING	Mar 03, 1995	Substantially Equivalent	Bio Med Sciences, Inc.
K942339	SKIN NEUVEAU SCAR TREATMENT	Nov 28, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K942695	TRI BLOCK POLUMER GEL SHEETING	Nov 10, 1994	Substantially Equivalent	Silipos, Inc.
K941197	SILK*SKIN SCAR TREATMENT	Aug 11, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K942156	EPI-DERM SILICONE GEL SHEETING	Jun 13, 1994	Substantially Equivalent	Biodermis Corp.
K941125	NOVAGEL SILICONE GEL SHEETING	May 31, 1994	Substantially Equivalent	Brennen Medical, Inc.
K933811	MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST	May 12, 1994	Substantially Equivalent	Pitt Enterprises (Silicone) , Ltd.
K925583	JOBSKIN CONTINUING CARE	Apr 04, 1994	Substantially Equivalent	Jobst Institute, Inc.
K935499	PMT SILICONE SHEETING	Feb 10, 1994	Substantially Equivalent	Pmt Corp.
K935803	CICA-CARE SILICONE GEL SHEET	Feb 03, 1994	Substantially Equivalent	Smith & Nephew United, Inc.
K934829	HASKON MEDICAL GRADE SHEETING	Feb 03, 1994	Substantially Equivalent	Haskon Intl., Inc.
K932048	SILICONE GEL SHEETING	Jan 07, 1994	Substantially Equivalent	Silipos, Inc.
K932214	SILON SILICONE GEL SHEET	Jan 06, 1994	Substantially Equivalent	Bio Med Sciences, Inc.
K930409	PMT(R) SILICONE GEL SHEETING MODEL 3505-1	Sep 01, 1993	Substantially Equivalent	Pmt Corp.
K914701	SIL-K	Jan 31, 1992	Substantially Equivalent	Degania Silicone , Ltd.
K913140	SILICONE GEL SHEETING	Sep 30, 1991	Substantially Equivalent	Cui Corp.
K901991	SILICONE ELASTOMER PUTTY	Sep 14, 1990	Substantially Equivalent	Crown Delta Corp.
K901990	VINYL SILICONE ELASTOMER MATERIAL	Sep 14, 1990	Substantially Equivalent	Crown Delta Corp.
K840113	SILICONE SPLINTING MATERIAL	Apr 17, 1985	Substantially Equivalent	General Dental Products, Inc.