← Product Code [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA) · K962013 # MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT (K962013) _Mentor Corp. · MDA · Aug 22, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K962013 ## Device Facts - **Applicant:** Mentor Corp. - **Product Code:** [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA.md) - **Decision Date:** Aug 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4025 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertrophic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. ## Device Story Mentor H/S Silicone Gel Sheeting treats hypertrophic and keloid scars; flattens/softens scar tissue; improves scar color. Device consists of silicone sheets reinforced with polyester mesh; supplied sterile. Used by patients or physicians; sheets cut to size to fit treatment area. Applied topically to scar site. Benefits include improved scar appearance and texture. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Silicone elastomer sheeting reinforced with polyester mesh. Supplied sterile. Form factor: cuttable sheets. ## Regulatory Identification Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars. ## Predicate Devices - DermaSof by McGhan Medical Corp. - Epi-Derm Silicone Gel Sheeting by Biodermis Corp. - TopiGel by CUI Corp. - Sil-K by Degania Silicone ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} AUG 22 1996 K962013 Page 1 of 2 # SUMMARY OF SAFETY AND EFFECTIVENESS ## MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT ### 510(k) SUMMARY 1. Submitter's Data Mentor Corporation 5425 Hollister Avenue Santa Barbara, CA 93111 Contact Person(s): Byron Wickett or Lynn Breckenridge Telephone: (805) 681-6000 Date Prepared: February, 1996 2. Device Name, Classification Name: Mentor H/S Silicone Gel Sheeting for Scar Management FDA Classification: Class II, Elastomer, Silicone, for Scar Management (FDA Code 79MDA) 3. Identification of Substantially Equivalent Devices DermaSof by McGhan Medical Corp. Epi-Derm Silicone Gel Sheeting by Biodermis Corp. TopiGel by CUI Corp. Sil-K by Degania Silicone 4. Device Description The Mentor H/S Silicone Gel Sheeting for Scar Management is designed to treat hypertropic and keloid scars. This therapy does not remove the scar, but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. The material will be supplied sterile in sheets of silicone reinforced with polyester mesh. The sheets may be cut by the patient and/or the physician to a desired size to fit the scar treatment area. **MENTOR CONFIDENTIAL** **TRADE SECRET** 000070 20°d 7009 189 508 S81676 80167638-80167638 SP:TT 966T-11-7n {1} TOTAL P. 03 K962013 Page 2 of 2 The Mentor H/S Silicone Gel Sheeting for Scar Management is indicated for treatment of hypertrophic and keloid scars. This therapy does not remove the scar but will flatten and soften the scar tissue as well as return a more natural palor to the scar area. ## 6. Contraindications for Use Clinical contraindications for use of the Mentor H/S Silicone Gel Sheeting for Scar Management may include use by patients with medical conditions that would prevent them from using and cleaning the dressing properly. This product should not be applied over an open wound. The product should not be used if the patient is known to be allergic to silicone elastomers or if a rash develops. ## 7. Warnings, Precautions Possible complications include: - skin rashes attributed to poor or insufficient hygiene - skin rashes attributed to the gel sheeting being applied too tightly - superficial maceration of the skin associated with an occlusive dressing - pruritis MENTOR CONFIDENTIAL TRADE SECRET 000071 JUL-11-1996 11:46 MENTOR-REGULATORY AFFAIRS 805 681 6004 P. 03 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K962013](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K962013) **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. 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