FDA Product Code
FDA Product Code MDA — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4025
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | 2011-09-29 | Traditional | PDF ↗ |
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | 2011-09-22 | Traditional | PDF ↗ |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | 2009-01-26 | Traditional | PDF ↗ |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | 2006-04-14 | Traditional | PDF ↗ |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | 2005-10-17 | Traditional | PDF ↗ |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | 2004-08-12 | Traditional | PDF ↗ |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | 2003-06-18 | Traditional | PDF ↗ |
| K024160 | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | 2003-03-17 | Traditional | PDF ↗ |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 | Traditional | PDF ↗ |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | 2002-10-16 | Special | PDF ↗ |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. | Medtrade Products , Ltd. | 2002-02-14 | Traditional | PDF ↗ |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 | Traditional | PDF ↗ |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 | Traditional | PDF ↗ |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | 2001-05-30 | Traditional | PDF ↗ |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 | Traditional | PDF ↗ |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | 2001-03-19 | Traditional | PDF ↗ |
| K003948 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 2001-01-29 | Traditional | PDF ↗ |
| K002488 | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | 2001-01-05 | Traditional | PDF ↗ |
| K002109 | OLEEVA FOAM | Bio Med Sciences, Inc. | 2000-08-31 | Traditional | PDF ↗ |
| K001608 | BLAINE SCARCARE PATCH | Blaine Labs, Inc. | 2000-07-25 | Traditional | PDF ↗ |
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | Spectrum Designs, Inc. | 1999-10-26 | Traditional | PDF ↗ |
| K991970 | SCAREASE SHEETS & SCAREASE GEL | Pillar Surgical | 1999-10-25 | Traditional | PDF ↗ |
| K991312 | SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING | Library Medical, Inc. | 1999-08-20 | Traditional | PDF ↗ |
| K990651 | SKIN 2 FORTE SILICONE SHEETING | United Hospital Technologies, Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K984029 | SILGEL STC-S | Nagor , Ltd. | 1999-08-05 | Traditional | PDF ↗ |
| K991968 | CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. | Smith & Nephew, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K992146 | SCARAID SILICONE GEL SHEETING | Biodermis Corp. | 1999-07-30 | Traditional | PDF ↗ |
| K991957 | CICACARE MANAGEMENT FOR SCARS | Smith & Nephew, Inc. | 1999-07-20 | Traditional | PDF ↗ |
| K991478 | TENDER TOUCH SILICONE GEL PADS | Capital Marketing Technologies, Inc. | 1999-06-21 | Traditional | PDF ↗ |
| K991630 | ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET | Advanced Medical Solutions Group Plc | 1999-06-11 | Traditional | PDF ↗ |
| K991604 | EPI-FOAM SILICONE SHEETING | Biodermis Corp. | 1999-06-09 | Traditional | PDF ↗ |
| K981353 | AVOGEL | Avocet Polymer Technologies, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K984213 | NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS | Capital Marketing Technologies, Inc. | 1999-04-14 | Traditional | PDF ↗ |
| K984115 | SCAREASE & SCAREASE ADHESIVE GEL | Scarease, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K982036 | SILON SCAR STRIPS | Bio Med Sciences, Inc. | 1998-08-06 | Traditional | PDF ↗ |
| K982051 | KELOCATE SHEETING | Allied Biomedical Corp. | 1998-08-05 | Traditional | PDF ↗ |
| K981902 | SPENCO SILICONE GEL SHEET | Spenco Medical Corp. | 1998-06-25 | Traditional | PDF ↗ |
| K981387 | EVANESCE SCAR MANAGEMENT SYSTEM | Medical Scientific, Inc. | 1998-06-10 | Traditional | PDF ↗ |
| K980563 | SKAR-KARE SHEET | Life Medical Sciences, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K974380 | REJUVENESS | Rejuveness Pharamceuticals, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K974172 | SILGEL TOPICAL GEL SHEET | Nagor , Ltd. | 1998-03-30 | Traditional | PDF ↗ |
| K974143 | KMC NEWSKIN | Kmc Intl. Co. | 1998-03-27 | Traditional | PDF ↗ |
| K974354 | MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE | Sca Molnlycke | 1998-03-05 | Traditional | PDF ↗ |
| K973271 | SKAR-KARE | Target Health, Inc. | 1997-11-19 | Traditional | PDF ↗ |
| K973572 | KELOCOTE SCAR GEL AND KELOCOTE LASER GEL | Hanson Medical, Inc. | 1997-10-21 | Traditional | PDF ↗ |
| K972597 | PMT NEW BEGINNINGS GELSHAPES & AMEND | Pmt Corp. | 1997-10-01 | Traditional | PDF ↗ |
| K971916 | MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL | Medical Z, S.A. | 1997-07-29 | Traditional | PDF ↗ |
| K971009 | SCAR CARE | Target Health, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K971482 | DEGANIA SILICONE SIL-K | Degania Silicone , Ltd. | 1997-06-24 | Traditional | PDF ↗ |
| K971468 | SCAR HEAL | Specialty Systems, Inc. | 1997-06-10 | Traditional | PDF ↗ |
| K970702 | SPECTRUM DESIGNS SPECTRAGEL | Spectrum Designs, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K964846 | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING | Implantech Associates, Inc. | 1997-02-12 | Traditional | PDF ↗ |
| K963128 | NOVAGEL SILICONE GEL SHEETING | Brennen Medical, Inc. | 1996-12-05 | Traditional | PDF ↗ |
| K961410 | DURASIL (MODIFICATION) | The S. F. Group, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K962013 | MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT | Mentor Corp. | 1996-08-22 | Traditional | PDF ↗ |
| K960254 | SILGEL TOPICAL GEL SHEET | Rofil Medical USA, Inc. | 1996-04-02 | Traditional | PDF ↗ |
| K955664 | STERILIZED TRI BLOCK POLYMER GEL SHEET | Silipos, Inc. | 1996-02-28 | Traditional | PDF ↗ |
| K954413 | KELOCOTE | Allied Biomedical Corp. | 1995-11-29 | Traditional | PDF ↗ |
| K952612 | DURASIL | The S. F. Group, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K953420 | SILK*SKIN SCAR TREATMENT | Silk*Skin Care Co. | 1995-09-26 | Traditional | PDF ↗ |
| K952546 | SILON SILICONE TEXTILE COMPOSITE | Bio Med Sciences, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K946362 | SILON SILICONE FOAM SHEETING | Bio Med Sciences, Inc. | 1995-07-13 | Traditional | PDF ↗ |
| K945892 | SILON(R) SILICONE THERMOPLASTIC SHEETING | Bio Med Sciences, Inc. | 1995-03-03 | Traditional | PDF ↗ |
| K942339 | SKIN NEUVEAU SCAR TREATMENT | Puritas Health Care, Inc. | 1994-11-28 | Traditional | PDF ↗ |
| K942695 | TRI BLOCK POLUMER GEL SHEETING | Silipos, Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K941197 | SILK*SKIN SCAR TREATMENT | Puritas Health Care, Inc. | 1994-08-11 | Traditional | PDF ↗ |
| K942156 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 1994-06-13 | Traditional | PDF ↗ |
| K941125 | NOVAGEL SILICONE GEL SHEETING | Brennen Medical, Inc. | 1994-05-31 | Traditional | PDF ↗ |
| K933811 | MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST | Pitt Enterprises (Silicone) , Ltd. | 1994-05-12 | Traditional | PDF ↗ |
| K925583 | JOBSKIN CONTINUING CARE | Jobst Institute, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K935499 | PMT SILICONE SHEETING | Pmt Corp. | 1994-02-10 | Traditional | PDF ↗ |
| K934829 | HASKON MEDICAL GRADE SHEETING | Haskon Intl., Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K935803 | CICA-CARE SILICONE GEL SHEET | Smith & Nephew United, Inc. | 1994-02-03 | Traditional | PDF ↗ |
| K932048 | SILICONE GEL SHEETING | Silipos, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K932214 | SILON SILICONE GEL SHEET | Bio Med Sciences, Inc. | 1994-01-06 | Traditional | PDF ↗ |
| K930409 | PMT(R) SILICONE GEL SHEETING MODEL 3505-1 | Pmt Corp. | 1993-09-01 | Traditional | PDF ↗ |
| K914701 | SIL-K | Degania Silicone , Ltd. | 1992-01-31 | Traditional | PDF ↗ |
| K913140 | SILICONE GEL SHEETING | Cui Corp. | 1991-09-30 | Traditional | PDF ↗ |
| K901990 | VINYL SILICONE ELASTOMER MATERIAL | Crown Delta Corp. | 1990-09-14 | Traditional | PDF ↗ |
| K901991 | SILICONE ELASTOMER PUTTY | Crown Delta Corp. | 1990-09-14 | Traditional | PDF ↗ |
| K840113 | SILICONE SPLINTING MATERIAL | General Dental Products, Inc. | 1985-04-17 | Traditional | PDF ↗ |
Product code MDA · Class I · General, Plastic Surgery. Data: openFDA.