← Product Code [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA) · K971009 # SCAR CARE (K971009) _Target Health, Inc. · MDA · Jul 29, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K971009 ## Device Facts - **Applicant:** Target Health, Inc. - **Product Code:** [MDA](/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA.md) - **Decision Date:** Jul 29, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4025 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use For the management of hypertrophic or keloid scars. ## Device Story SCAR CARE™ is a topical dressing for hypertrophic and keloid scars. Device consists of an outer shell of medical-grade silicone sheets sealed together, containing an internal component of medical-grade silicone oil. It is a soft, semi-transparent, rubbery dressing applied topically to the scar site. The device functions as a physical barrier/dressing to manage scar tissue. It is intended for prescription use. ## Clinical Evidence No clinical data provided; substantial equivalence is based on technological characteristics and intended use. ## Technological Characteristics Topical dressing; materials: medical-grade silicone sheets and medical-grade silicone oil; form factor: soft, semi-transparent, rubbery sheet; non-powered; no software or electronic components. ## Regulatory Identification Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars. ## Predicate Devices - TopiGel™ Gel Sheeting ([K913140](/device/K913140.md)) ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Jules T. Mitchell Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, New York 10017 JUL 29 1997 Re: K971009 Trade Name: SCAR CARE™ Regulatory Class: Unclassified Product Code: MDA Dated: June 17, 1997 Received: June 17, 1997 Dear Dr. Mitchell: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} Page 2 - Dr. Jules T. Mitchell This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, ![img-0.jpeg](img-0.jpeg) Enclosure {2} K971009 Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837 JUL 29 1997 SCAR CARE™ 510(K) Number: K971009 Amendment 1: March 28, 1997 Amendment 2: June 17, 1997 12.510(k) Summary SCAR CARE™ FOR THE KELOID SCARS MANAGEMENT OF HYPERTROPHIC OR Contact: Target Health, Inc. 310 Madison Avenue, 22nd Floor New York, NY 10017 Tel: 212 681 2100 Fax: 212 682 0151 Sponsor: Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837-2227 USA Dr. Eli Pines Tel: 908 494 0444 Fax: 908 494 6252 Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc. This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc. 14 {3} Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837 SCAR CARE™ 510(K) Number: K971009 Amendment 1: March 28, 1997 Amendment 2: June 17, 1997 a. Device Name SCAR CARE™ is provided as follows: a. Trade Name - SCAR CARE™ b. Common Name - Topical dressing for hypertrophic and keloid scars c. Classification Name - Not available b. Predicate Device/ Company Names and Addresses The predicate device is listed below with its 510(k) clearance number. | TopiGel™ Gel Sheeting | K 913140 | CUI Corporation PO Box 40288 Santa Barbara, CA 93140 | | --- | --- | --- | c. Description of Device SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device. d. Intended Use For the management of hypertrophic or keloid scars. Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc. This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc. 15 012 {4} k971009 Life Medical Sciences, Inc. 379 Thornall Street Edison, NJ 08837 SCAR CARE™ 510(K) Number: K971009 Amendment 1: March 28, 1997 Amendment 2: June 17, 1997 # INDICATION FOR USE SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars. ![img-1.jpeg](img-1.jpeg) (Division Sign-Off) Division of General Restorative Devices 510(k) Number K971009 Prescription Use ☑ (Per 21 CFR 801.109) Over-the-Counter Use Notice: This document is proprietary and its contents are the exclusive property of Life Medical Sciences, Inc. This document may not be reproduced in any form without the specific permission of Life Medical Sciences, Inc. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K971009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MDA/K971009) **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