Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4025](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4025) → MDA — Elastomer, Silicone, For Scar Management # MDA · Elastomer, Silicone, For Scar Management _General, Plastic Surgery · 21 CFR 878.4025 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA ## Overview - **Product Code:** MDA - **Device Name:** Elastomer, Silicone, For Scar Management - **Regulation:** [21 CFR 878.4025](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4025) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K112131.md) | NEODYNE DRESSING | Neodyne Biosciences, Inc. | Sep 29, 2011 | SESE | | [K111733](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K111733.md) | CORELEADER SCAR-DIMMER | Coreleader Biotech Co., Ltd. | Sep 22, 2011 | SESE | | [K083718](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K083718.md) | BEAU RX SCAR CARE GEL | Beau RX Solutions, LLC | Jan 26, 2009 | SESE | | [K053481](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K053481.md) | KELO-COTE SPRAY | Advanced Bio-Technologies, Inc. | Apr 14, 2006 | SESE | | [K041704](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K041704.md) | NEWGEL AND NEWGEL PLUS E | Newmedical Technology, Inc. | Oct 17, 2005 | SESE | | [K040307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K040307.md) | HANSON SCAR ADE | Hanson Medical, Inc. | Aug 12, 2004 | SESE | | [K024057](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K024057.md) | CURAD SCAR THERAPY | Beiersdorf, Inc. | Jun 18, 2003 | SESE | | [K024160](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K024160.md) | NEOSPORIN SCAR SOLUTION | Warner-Lambert Co. | Mar 17, 2003 | SESE | | [K023678](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K023678.md) | DIMISIL SCAR GEL | Aesthetic and Reconstructive Technologies, Inc. | Jan 23, 2003 | SESE | | [K023136](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K023136.md) | OLEEVA FABRIC | Bio Med Sciences, Inc. | Oct 16, 2002 | SESE | | [K014036](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K014036.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K013732.md) | GELZONE | Implantech Associates, Inc. | Feb 7, 2002 | SESE | | [K012419](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K012419.md) | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | Oct 24, 2001 | SESE | | [K010675](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K010675.md) | ENSIL FABRIC | Gottfried Medical, Inc. | May 30, 2001 | SESE | | [K010245](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K010245.md) | ACTIVHEAL SCAR MANAGEMENT DRESSING | Advanced Medical Solutions, Ltd. | Apr 25, 2001 | SESE | | [K003979](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K003979.md) | MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD | Medtrade Products , Ltd. | Mar 19, 2001 | SESE | | [K003948](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K003948.md) | EPI-DERM SILICONE GEL SHEETING | Biodermis Corp. | Jan 29, 2001 | SESE | | [K002488](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K002488.md) | KELO-COTE TOPICAL GEL | Advanced Bio-Technologies, Inc. | Jan 5, 2001 | SESE | | [K002109](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K002109.md) | OLEEVA FOAM | Bio Med Sciences, Inc. | Aug 31, 2000 | SESE | | [K001608](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K001608.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com