CORELEADER SCAR-DIMMER

K111733 · Coreleader Biotech Co., Ltd. · MDA · Sep 22, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111733
• Device Name: CORELEADER SCAR-DIMMER
• Applicant: Coreleader Biotech Co., Ltd.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Coreleader Scar-D Silicone Sheeting is intended for use in the management of closed hypertrophic and keloid scars.

Device Story

Coreleader Scar-D Silicone Sheeting is a thin, soft, self-adhesive medical-grade silicone dressing designed for scar management. The device is applied topically to closed hypertrophic or keloid scars. It functions by maintaining moisture and applying pressure to the scar tissue, which helps hydrate and soften the tissue, potentially reducing healing time. The sheets are non-sterile, washable, and can be cut or trimmed to fit the specific size of the scar. It is intended for use by patients or clinicians to manage scar appearance.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Medical-grade silicone dressing with PU foam/PU non-woven film backing and polyester release paper. Dimensions: 0.6 mm thick; various sizes (5x8 cm, 5x20 cm, 2.5x100 cm, 5x100 cm). Self-adhesive, washable, non-sterile. Mechanism: hydration and pressure application to scar tissue.

Indications for Use

Indicated for the management of closed hypertrophic and keloid scars. Not for use on open wounds.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Predicate Devices

• BIODERMIS CORP., K003948, EPI-DERM SILICONE GEL SHEETING
• SMITH & NEPHEW UNITED, INC., K935803, CICA-CARE SILICONE GEL SHEET

Submission Summary (Full Text)

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K 111733
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Chapter 5 510(K) Summary

SEP 2 2 2011

## 510(k) Summary

| Submitted by: | Coreleader Biotech Co., Ltd.<br>19F, No. 100, Sec. 1, Sintai 5th Rd., Sijhih Dist., New<br>Taipei City, Taiwan (R.O.C), 22102<br>Phone: [phone]<br>FAX: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Teeming Tsao |
| Date Prepared: | May 25, 2011 |
| Proprietary Name: | Coreleader Scar-D Silicone Sheeting |
| Common Name: | Silicone Sheeting |
| Classification: | Unclassified |
| Classification Name: | Elastomer, silicone, for scar management |
| Predicate Device: | BIODERMIS CORP., K003948, EPI-DERM SILICONE<br>GEL SHEETING<br>SMITH & NEPHEW UNITED, INC., K935803,<br>CICA-CARE SILICONE GEL SHEET |
| Device Description: | Coreleader Scar-D silicone sheeting is a thin, soft and<br>self-adhesive sheet made from medical grade silicone with<br>a PU Foam/PU non-woven film backing paper and a non-<br>silicone polyester release paper. It is able to hold moisture<br>with adequate pressure on the scar.<br>The sheets are rectangular and come in four sizes, 5 cm x 8<br>cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm.<br>They are approximately 0.6 mm thick. The sheet maybe cut |

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K 11 1 733
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## Chapter 5 510(K) Summary

or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.

Coreleader Scar-D Silicone Sheeting is intended for use in Intended Use: the management of closed hypertrophic and keloid scars.

Technological Characteristics:

Coreleader Scar-D Silicone Sheeting is a thin, soft and self-adhesive medical grade silicone dressing. It is able to hold moisture with adequate pressure on the scar. Properties of silicone have been observed to hydrate scar tissue, soften it, and therefore aid in reducing the healing time of scars.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Coreleader Biotech Co.. Lid. % Mr. lan Li 19 F, No. 100, Sec. 1, Sintai 500 Rd., Sijhih Dist.. New Taipei City Taiwan (R.O.C) 22102

SEP 2 2 2011

Re: K111733 Trade/Device Name: Scar-D Silicone Sheeting Regulation Number: 21 CFR 878.4025 Regulation Name: Silicone sheeting Regulatory Class: 1 Product Code: MDA Dated: August 16, 2011 Received: August 30. 2011

Dear Mr. Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and fisting (21

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Page 2 - Mr. Ian Li

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofie the [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely your

For

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):K111733

Device Name: Coreleader Scar-D Silicone Sheeting

Indications for Use:

Coreleader Scar-D Silicone Sheeting is intended for use:

for the management of closed hypertrophic and keloid scars. ◆

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Division of Surgical. Orthopedic, and Restorative Devices

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510(k) Number K111733