Atlas FDA

MDA

81 FDA 510(k) clearances · Product code

90 daysmedian time to decision
218 days90th percentile
81clearances measured

FDA profile

Official device name
Elastomer, Silicone, For Scar Management
Device class
Class I (low risk)
Regulation
21 CFR 878.4025
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2006: 2 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NEODYNE DRESSING (K112131)Neodyne Biosciences, Inc.2011-09-29
CORELEADER SCAR-DIMMER (K111733)Coreleader Biotech Co., Ltd.2011-09-22
BEAU RX SCAR CARE GEL (K083718)Beau RX Solutions, LLC2009-01-26
KELO-COTE SPRAY (K053481)Advanced Bio-Technologies, Inc.2006-04-14
NEWGEL AND NEWGEL PLUS E (K041704)Newmedical Technology, Inc.2005-10-17
HANSON SCAR ADE (K040307)Hanson Medical, Inc.2004-08-12
CURAD SCAR THERAPY (K024057)Beiersdorf, Inc.2003-06-18
NEOSPORIN SCAR SOLUTION (K024160)Warner-Lambert Co.2003-03-17
DIMISIL SCAR GEL (K023678)Aesthetic and Reconstructive Technologies, Inc.2003-01-23
OLEEVA FABRIC (K023136)Bio Med Sciences, Inc.2002-10-16
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. (K014036)Medtrade Products , Ltd.2002-02-14
GELZONE (K013732)Implantech Associates, Inc.2002-02-07
CONFORM SHEETING, MODEL IGEL (K012419)Implantech Associates, Inc.2001-10-24
ENSIL FABRIC (K010675)Gottfried Medical, Inc.2001-05-30
ACTIVHEAL SCAR MANAGEMENT DRESSING (K010245)Advanced Medical Solutions, Ltd.2001-04-25
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD (K003979)Medtrade Products , Ltd.2001-03-19
EPI-DERM SILICONE GEL SHEETING (K003948)Biodermis Corp.2001-01-29
KELO-COTE TOPICAL GEL (K002488)Advanced Bio-Technologies, Inc.2001-01-05
OLEEVA FOAM (K002109)Bio Med Sciences, Inc.2000-08-31
BLAINE SCARCARE PATCH (K001608)Blaine Labs, Inc.2000-07-25
SPECTRUM DESIGNS SPECTRAGEL (K992522)Spectrum Designs, Inc.1999-10-26
SCAREASE SHEETS & SCAREASE GEL (K991970)Pillar Surgical1999-10-25
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING (K991312)Library Medical, Inc.1999-08-20
SKIN 2 FORTE SILICONE SHEETING (K990651)United Hospital Technologies, Inc.1999-08-13
SILGEL STC-S (K984029)Nagor , Ltd.1999-08-05
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. (K991968)Smith & Nephew, Inc.1999-07-30
SCARAID SILICONE GEL SHEETING (K992146)Biodermis Corp.1999-07-30
CICACARE MANAGEMENT FOR SCARS (K991957)Smith & Nephew, Inc.1999-07-20
TENDER TOUCH SILICONE GEL PADS (K991478)Capital Marketing Technologies, Inc.1999-06-21
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET (K991630)Advanced Medical Solutions Group Plc1999-06-11
EPI-FOAM SILICONE SHEETING (K991604)Biodermis Corp.1999-06-09
AVOGEL (K981353)Avocet Polymer Technologies, Inc.1999-06-01
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS (K984213)Capital Marketing Technologies, Inc.1999-04-14
SCAREASE & SCAREASE ADHESIVE GEL (K984115)Scarease, Inc.1999-02-12
SILON SCAR STRIPS (K982036)Bio Med Sciences, Inc.1998-08-06
KELOCATE SHEETING (K982051)Allied Biomedical Corp.1998-08-05
SPENCO SILICONE GEL SHEET (K981902)Spenco Medical Corp.1998-06-25
EVANESCE SCAR MANAGEMENT SYSTEM (K981387)Medical Scientific, Inc.1998-06-10
SKAR-KARE SHEET (K980563)Life Medical Sciences, Inc.1998-05-20
REJUVENESS (K974380)Rejuveness Pharamceuticals, Inc.1998-04-03
SILGEL TOPICAL GEL SHEET (K974172)Nagor , Ltd.1998-03-30
KMC NEWSKIN (K974143)Kmc Intl. Co.1998-03-27
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE (K974354)Sca Molnlycke1998-03-05
SKAR-KARE (K973271)Target Health, Inc.1997-11-19
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL (K973572)Hanson Medical, Inc.1997-10-21
PMT NEW BEGINNINGS GELSHAPES & AMEND (K972597)Pmt Corp.1997-10-01
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL (K971916)Medical Z, S.A.1997-07-29
SCAR CARE (K971009)Target Health, Inc.1997-07-29
DEGANIA SILICONE SIL-K (K971482)Degania Silicone , Ltd.1997-06-24
SCAR HEAL (K971468)Specialty Systems, Inc.1997-06-10
SPECTRUM DESIGNS SPECTRAGEL (K970702)Spectrum Designs, Inc.1997-05-12
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING (K964846)Implantech Associates, Inc.1997-02-12
NOVAGEL SILICONE GEL SHEETING (K963128)Brennen Medical, Inc.1996-12-05
DURASIL (MODIFICATION) (K961410)The S. F. Group, Inc.1996-09-03
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT (K962013)Mentor Corp.1996-08-22
SILGEL TOPICAL GEL SHEET (K960254)Rofil Medical USA, Inc.1996-04-02
STERILIZED TRI BLOCK POLYMER GEL SHEET (K955664)Silipos, Inc.1996-02-28
KELOCOTE (K954413)Allied Biomedical Corp.1995-11-29
DURASIL (K952612)The S. F. Group, Inc.1995-11-22
SILK*SKIN SCAR TREATMENT (K953420)Silk*Skin Care Co.1995-09-26
SILON SILICONE TEXTILE COMPOSITE (K952546)Bio Med Sciences, Inc.1995-08-07
SILON SILICONE FOAM SHEETING (K946362)Bio Med Sciences, Inc.1995-07-13
SILON(R) SILICONE THERMOPLASTIC SHEETING (K945892)Bio Med Sciences, Inc.1995-03-03
SKIN NEUVEAU SCAR TREATMENT (K942339)Puritas Health Care, Inc.1994-11-28
TRI BLOCK POLUMER GEL SHEETING (K942695)Silipos, Inc.1994-11-10
SILK*SKIN SCAR TREATMENT (K941197)Puritas Health Care, Inc.1994-08-11
EPI-DERM SILICONE GEL SHEETING (K942156)Biodermis Corp.1994-06-13
NOVAGEL SILICONE GEL SHEETING (K941125)Brennen Medical, Inc.1994-05-31
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST (K933811)Pitt Enterprises (Silicone) , Ltd.1994-05-12
JOBSKIN CONTINUING CARE (K925583)Jobst Institute, Inc.1994-04-04
PMT SILICONE SHEETING (K935499)Pmt Corp.1994-02-10
HASKON MEDICAL GRADE SHEETING (K934829)Haskon Intl., Inc.1994-02-03
CICA-CARE SILICONE GEL SHEET (K935803)Smith & Nephew United, Inc.1994-02-03
SILICONE GEL SHEETING (K932048)Silipos, Inc.1994-01-07
SILON SILICONE GEL SHEET (K932214)Bio Med Sciences, Inc.1994-01-06
PMT(R) SILICONE GEL SHEETING MODEL 3505-1 (K930409)Pmt Corp.1993-09-01
SIL-K (K914701)Degania Silicone , Ltd.1992-01-31
SILICONE GEL SHEETING (K913140)Cui Corp.1991-09-30
SILICONE ELASTOMER PUTTY (K901991)Crown Delta Corp.1990-09-14
VINYL SILICONE ELASTOMER MATERIAL (K901990)Crown Delta Corp.1990-09-14
SILICONE SPLINTING MATERIAL (K840113)General Dental Products, Inc.1985-04-17

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Every clearance here is in the API, with alerts when new ones post.