Elastomer, Silicone, For Scar Management

FDA product code MDA · 81 cleared devices

Class 1 General, Plastic Surgery

Regulation: 21 CFR 878.4025
Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-04-17 – 2011-09-29

MDA 2011-09-29

NEODYNE DRESSING

Applicant Neodyne Biosciences, Inc.

K number K112131

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MDA 2011-09-22

CORELEADER SCAR-DIMMER

Applicant Coreleader Biotech Co., Ltd.

K number K111733

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MDA 2009-01-26

BEAU RX SCAR CARE GEL

Applicant Beau RX Solutions, LLC

K number K083718

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MDA 2006-04-14

KELO-COTE SPRAY

Applicant Advanced Bio-Technologies, Inc.

K number K053481

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MDA 2005-10-17

NEWGEL AND NEWGEL PLUS E

Applicant Newmedical Technology, Inc.

K number K041704

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MDA 2004-08-12

HANSON SCAR ADE

Applicant Hanson Medical, Inc.

K number K040307

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MDA 2003-06-18

CURAD SCAR THERAPY

Applicant Beiersdorf, Inc.

K number K024057

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MDA 2003-03-17

NEOSPORIN SCAR SOLUTION

Applicant Warner-Lambert Co.

K number K024160

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MDA 2003-01-23

DIMISIL SCAR GEL

Applicant Aesthetic and Reconstructive Technologies, Inc.

K number K023678

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MDA 2002-10-16

OLEEVA FABRIC

Applicant Bio Med Sciences, Inc.

K number K023136

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MDA 2002-02-14

MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.

Applicant Medtrade Products , Ltd.

K number K014036

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MDA 2002-02-07

GELZONE

Applicant Implantech Associates, Inc.

K number K013732

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MDA 2001-10-24

CONFORM SHEETING, MODEL IGEL

Applicant Implantech Associates, Inc.

K number K012419

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MDA 2001-05-30

ENSIL FABRIC

Applicant Gottfried Medical, Inc.

K number K010675

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MDA 2001-04-25

ACTIVHEAL SCAR MANAGEMENT DRESSING

Applicant Advanced Medical Solutions, Ltd.

K number K010245

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MDA 2001-03-19

MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD

Applicant Medtrade Products , Ltd.

K number K003979

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MDA 2001-01-29

EPI-DERM SILICONE GEL SHEETING

Applicant Biodermis Corp.

K number K003948

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MDA 2001-01-05

KELO-COTE TOPICAL GEL

Applicant Advanced Bio-Technologies, Inc.

K number K002488

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MDA 2000-08-31

OLEEVA FOAM

Applicant Bio Med Sciences, Inc.

K number K002109

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MDA 2000-07-25

BLAINE SCARCARE PATCH

Applicant Blaine Labs, Inc.

K number K001608

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MDA 1999-10-26

SPECTRUM DESIGNS SPECTRAGEL

Applicant Spectrum Designs, Inc.

K number K992522

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MDA 1999-10-25

SCAREASE SHEETS & SCAREASE GEL

Applicant Pillar Surgical

K number K991970

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MDA 1999-08-20

SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING

Applicant Library Medical, Inc.

K number K991312

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MDA 1999-08-13

SKIN 2 FORTE SILICONE SHEETING

Applicant United Hospital Technologies, Inc.

K number K990651

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MDA 1999-08-05

SILGEL STC-S

Applicant Nagor , Ltd.

K number K984029

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MDA 1999-07-30

SCARAID SILICONE GEL SHEETING

Applicant Biodermis Corp.

K number K992146

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MDA 1999-07-30

CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.

Applicant Smith & Nephew, Inc.

K number K991968

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MDA 1999-07-20

CICACARE MANAGEMENT FOR SCARS

Applicant Smith & Nephew, Inc.

K number K991957

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MDA 1999-06-21

TENDER TOUCH SILICONE GEL PADS

Applicant Capital Marketing Technologies, Inc.

K number K991478

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MDA 1999-06-11

ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET

Applicant Advanced Medical Solutions Group Plc

K number K991630

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MDA 1999-06-09

EPI-FOAM SILICONE SHEETING

Applicant Biodermis Corp.

K number K991604

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MDA 1999-06-01

AVOGEL

Applicant Avocet Polymer Technologies, Inc.

K number K981353

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MDA 1999-04-14

NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS

Applicant Capital Marketing Technologies, Inc.

K number K984213

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MDA 1999-02-12

SCAREASE & SCAREASE ADHESIVE GEL

Applicant Scarease, Inc.

K number K984115

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MDA 1998-08-06

SILON SCAR STRIPS

Applicant Bio Med Sciences, Inc.

K number K982036

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MDA 1998-08-05

KELOCATE SHEETING

Applicant Allied Biomedical Corp.

K number K982051

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MDA 1998-06-25

SPENCO SILICONE GEL SHEET

Applicant Spenco Medical Corp.

K number K981902

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MDA 1998-06-10

EVANESCE SCAR MANAGEMENT SYSTEM

Applicant Medical Scientific, Inc.

K number K981387

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MDA 1998-05-20

SKAR-KARE SHEET

Applicant Life Medical Sciences, Inc.

K number K980563

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MDA 1998-04-03

REJUVENESS

Applicant Rejuveness Pharamceuticals, Inc.

K number K974380

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MDA 1998-03-30

SILGEL TOPICAL GEL SHEET

Applicant Nagor , Ltd.

K number K974172

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MDA 1998-03-27

KMC NEWSKIN

Applicant Kmc Intl. Co.

K number K974143

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MDA 1998-03-05

MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE

Applicant Sca Molnlycke

K number K974354

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MDA 1997-11-19

SKAR-KARE

Applicant Target Health, Inc.

K number K973271

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MDA 1997-10-21

KELOCOTE SCAR GEL AND KELOCOTE LASER GEL

Applicant Hanson Medical, Inc.

K number K973572

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MDA 1997-10-01

PMT NEW BEGINNINGS GELSHAPES & AMEND

Applicant Pmt Corp.

K number K972597

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MDA 1997-07-29

MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL

Applicant Medical Z, S.A.

K number K971916

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MDA 1997-07-29

SCAR CARE

Applicant Target Health, Inc.

K number K971009

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MDA 1997-06-24

DEGANIA SILICONE SIL-K

Applicant Degania Silicone , Ltd.

K number K971482

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MDA 1997-06-10

SCAR HEAL

Applicant Specialty Systems, Inc.

K number K971468

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MDA 1997-05-12

SPECTRUM DESIGNS SPECTRAGEL

Applicant Spectrum Designs, Inc.

K number K970702

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MDA 1997-02-12

IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING

Applicant Implantech Associates, Inc.

K number K964846

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MDA 1996-12-05

NOVAGEL SILICONE GEL SHEETING

Applicant Brennen Medical, Inc.

K number K963128

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MDA 1996-09-03

DURASIL (MODIFICATION)

Applicant The S. F. Group, Inc.

K number K961410

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MDA 1996-08-22

MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT

Applicant Mentor Corp.

K number K962013

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MDA 1996-04-02

SILGEL TOPICAL GEL SHEET

Applicant Rofil Medical USA, Inc.

K number K960254

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MDA 1996-02-28

STERILIZED TRI BLOCK POLYMER GEL SHEET

Applicant Silipos, Inc.

K number K955664

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MDA 1995-11-29

KELOCOTE

Applicant Allied Biomedical Corp.

K number K954413

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MDA 1995-11-22

DURASIL

Applicant The S. F. Group, Inc.

K number K952612

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MDA 1995-09-26

SILK*SKIN SCAR TREATMENT

Applicant Silk*Skin Care Co.

K number K953420

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MDA 1995-08-07

SILON SILICONE TEXTILE COMPOSITE

Applicant Bio Med Sciences, Inc.

K number K952546

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MDA 1995-07-13

SILON SILICONE FOAM SHEETING

Applicant Bio Med Sciences, Inc.

K number K946362

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MDA 1995-03-03

SILON(R) SILICONE THERMOPLASTIC SHEETING

Applicant Bio Med Sciences, Inc.

K number K945892

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MDA 1994-11-28

SKIN NEUVEAU SCAR TREATMENT

Applicant Puritas Health Care, Inc.

K number K942339

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MDA 1994-11-10

TRI BLOCK POLUMER GEL SHEETING

Applicant Silipos, Inc.

K number K942695

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MDA 1994-08-11

SILK*SKIN SCAR TREATMENT

Applicant Puritas Health Care, Inc.

K number K941197

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MDA 1994-06-13

EPI-DERM SILICONE GEL SHEETING

Applicant Biodermis Corp.

K number K942156

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MDA 1994-05-31

NOVAGEL SILICONE GEL SHEETING

Applicant Brennen Medical, Inc.

K number K941125

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MDA 1994-05-12

MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST

Applicant Pitt Enterprises (Silicone) , Ltd.

K number K933811

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MDA 1994-04-04

JOBSKIN CONTINUING CARE

Applicant Jobst Institute, Inc.

K number K925583

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MDA 1994-02-10

PMT SILICONE SHEETING

Applicant Pmt Corp.

K number K935499

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MDA 1994-02-03

CICA-CARE SILICONE GEL SHEET

Applicant Smith & Nephew United, Inc.

K number K935803

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MDA 1994-02-03

HASKON MEDICAL GRADE SHEETING

Applicant Haskon Intl., Inc.

K number K934829

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MDA 1994-01-07

SILICONE GEL SHEETING

Applicant Silipos, Inc.

K number K932048

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MDA 1994-01-06

SILON SILICONE GEL SHEET

Applicant Bio Med Sciences, Inc.

K number K932214

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MDA 1993-09-01

PMT(R) SILICONE GEL SHEETING MODEL 3505-1

Applicant Pmt Corp.

K number K930409

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MDA 1992-01-31

SIL-K

Applicant Degania Silicone , Ltd.

K number K914701

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MDA 1991-09-30

SILICONE GEL SHEETING

Applicant Cui Corp.

K number K913140

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MDA 1990-09-14

SILICONE ELASTOMER PUTTY

Applicant Crown Delta Corp.

K number K901991

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MDA 1990-09-14

VINYL SILICONE ELASTOMER MATERIAL

Applicant Crown Delta Corp.

K number K901990

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MDA 1985-04-17

SILICONE SPLINTING MATERIAL

Applicant General Dental Products, Inc.

K number K840113

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