Product code MDA
- Device name
- Elastomer, Silicone, For Scar Management
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4025
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | 2011-09-29 |
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | 2011-09-22 |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | 2009-01-26 |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | 2006-04-14 |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | 2005-10-17 |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | 2004-08-12 |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | 2003-06-18 |
| K024160 | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | 2003-03-17 |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | 2003-01-23 |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | 2002-10-16 |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. | Medtrade Products , Ltd. | 2002-02-14 |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | 2001-05-30 |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | 2001-04-25 |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | 2001-03-19 |
| K003948 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | 2001-01-29 |
| K002488 | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | 2001-01-05 |
| K002109 | OLEEVA FOAM | Bio Med Sciences, Inc. | 2000-08-31 |
| K001608 | BLAINE SCARCARE PATCH | Blaine Labs, Inc. | 2000-07-25 |
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | Spectrum Designs, Inc. | 1999-10-26 |
| K991970 | SCAREASE SHEETS & SCAREASE GEL | Pillar Surgical | 1999-10-25 |
| K991312 | SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING | Library Medical, Inc. | 1999-08-20 |
| K990651 | SKIN 2 FORTE SILICONE SHEETING | United Hospital Technologies, Inc. | 1999-08-13 |
| K984029 | SILGEL STC-S | Nagor , Ltd. | 1999-08-05 |
| K992146 | SCARAID SILICONE GEL SHEETING | Biodermis Corp. | 1999-07-30 |
| K991968 | CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. | Smith & Nephew, Inc. | 1999-07-30 |
| K991957 | CICACARE MANAGEMENT FOR SCARS | Smith & Nephew, Inc. | 1999-07-20 |
| K991478 | TENDER TOUCH SILICONE GEL PADS | Capital Marketing Technologies, Inc. | 1999-06-21 |
| K991630 | ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET | Advanced Medical Solutions Group Plc | 1999-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00358962203107 | ScarAway Silicone Scar Gel | Alliance Pharma Inc. | 2024-04-09 |
| 00810050460293 | Oleeva Clear 5x5 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460286 | Oleeva Clear 1.5x5 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460279 | Oleeva Clear 1.5x3 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460262 | Oleeva Foam Vertical Mastopexy Shape | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460255 | Oleeva Foam C-Section | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460248 | Oleeva Foam Breast Kit | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460231 | Oleeva Foam Breast Anchor Shape | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460224 | Oleeva Foam 5.2x2.2 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460217 | Oleeva Foam Breast Areola Shape | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460200 | Oleeva Foam Abdominoplasty Shape | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460194 | Oleeva Foam 11x12 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460187 | Oleeva Foam 5x10 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460170 | Oleeva Foam 5x5 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810050460163 | Oleeva Foam 1.5x5 | Bio Med Sciences, Inc. | 2023-12-31 |
| 00810040131783 | Simpurity | SAFE N' SIMPLE LLC | 2023-02-05 |
| 00810040131714 | Simpurity | SAFE N' SIMPLE LLC | 2023-02-05 |
| 00810040131684 | Simpurity | SAFE N' SIMPLE LLC | 2023-02-05 |
| 00810040131653 | Simpurity | SAFE N' SIMPLE LLC | 2023-02-05 |
| 30884389103184 | Curad | MEDLINE INDUSTRIES, INC. | 2022-04-08 |
| 14711182607002 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | 2021-12-13 |
| 14711182607026 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | 2021-12-13 |
| 14711182607019 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | 2021-12-13 |
| 00070030511739 | SCARAWAY SILICONE GEL 20G | L PERRIGO COMPANY | 2021-03-17 |
| 15060295491220 | SilDerm Scar Gel Sachet | SKINGEN UK LTD | 2020-08-31 |
| 15060295490100 | SilDerm Scar Spray | SKINGEN UK LTD | 2020-08-31 |
| 15060295490094 | SilDerm Scar Spray | SKINGEN UK LTD | 2020-08-31 |
| 15060295490056 | SilDerm Scar Gel | SKINGEN UK LTD | 2020-08-31 |
| 15060295490032 | SilDerm Scar Gel | SKINGEN UK LTD | 2020-08-31 |
| 15060295490001 | SilDerm Scar Spray | SKINGEN UK LTD | 2020-08-31 |