MDA · Elastomer, Silicone, For Scar Management
General, Plastic Surgery · 21 CFR 878.4025 · Class 1
Overview
| Product Code | MDA |
|---|---|
| Device Name | Elastomer, Silicone, For Scar Management |
| Regulation | 21 CFR 878.4025 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 81)
Showing 20 most recent of 81 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112131 | NEODYNE DRESSING | Neodyne Biosciences, Inc. | Sep 29, 2011 | SESE |
| K111733 | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | Sep 22, 2011 | SESE |
| K083718 | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | Jan 26, 2009 | SESE |
| K053481 | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | Apr 14, 2006 | SESE |
| K041704 | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | Oct 17, 2005 | SESE |
| K040307 | HANSON SCAR ADE | Hanson Medical, Inc. | Aug 12, 2004 | SESE |
| K024057 | CURAD SCAR THERAPY | Beiersdorf, Inc. | Jun 18, 2003 | SESE |
| K024160 | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | Mar 17, 2003 | SESE |
| K023678 | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | Jan 23, 2003 | SESE |
| K023136 | OLEEVA FABRIC | Bio Med Sciences, Inc. | Oct 16, 2002 | SESE |
| K014036 | MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. | Medtrade Products , Ltd. | Feb 14, 2002 | SESE |
| K013732 | GELZONE | Implantech Associates, Inc. | Feb 7, 2002 | SESE |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | Oct 24, 2001 | SESE |
| K010675 | ENSIL FABRIC | Gottfried Medical, Inc. | May 30, 2001 | SESE |
| K010245 | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | Apr 25, 2001 | SESE |
| K003979 | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | Mar 19, 2001 | SESE |
| K003948 | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | Jan 29, 2001 | SESE |
| K002488 | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | Jan 5, 2001 | SESE |
| K002109 | OLEEVA FOAM | Bio Med Sciences, Inc. | Aug 31, 2000 | SESE |
| K001608 | BLAINE SCARCARE PATCH | Blaine Labs, Inc. | Jul 25, 2000 | SESE |
Top Applicants
- Bio Med Sciences, Inc. — 7 clearances
- Biodermis Corp. — 4 clearances
- Silipos, Inc. — 3 clearances
- Pmt Corp. — 3 clearances
- Implantech Associates, Inc. — 3 clearances
