Coreleader Scar-Dimmer
FDA 510(k) K111733 · Coreleader Biotech Co., Ltd.
510(k) numberK111733
Submission
- Device name
- Coreleader Scar-Dimmer
- Applicant
- Coreleader Biotech Co., Ltd.
New Taipei, Taiwan, TW - Received
- June 21, 2011
- Decision date
- September 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDA – Elastomer, Silicone, For Scar Management
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4025
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code MDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112131 | Neodyne DressingMDA · Traditional | Neodyne Biosciences, Inc. | 09/29/2011SE |
| K083718 | Beau RX Scar Care GelMDA · Traditional | Beau RX Solutions, LLC | 01/26/2009SE |
| K053481 | Kelo-Cote SprayMDA · Traditional | Advanced Bio-Technologies, Inc. | 04/14/2006SE |
| K041704 | Newgel and Newgel Plus EMDA · Traditional | Newmedical Technology, Inc. | 10/17/2005SE |
| K040307 | Hanson Scar AdeMDA · Traditional | Hanson Medical, Inc. | 08/12/2004SE |
| K024057 | Curad Scar TherapyMDA · Traditional | Beiersdorf, Inc. | 06/18/2003SE |
| K024160 | Neosporin Scar SolutionMDA · Traditional | Warner-Lambert Co. | 03/17/2003SE |
| K023678 | Dimisil Scar GelMDA · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 01/23/2003SE |
| K023136 | Oleeva FabricMDA · Special | Bio Med Sciences, Inc. | 10/16/2002SE |
| K014036 | Medtrade Products Silicone Scar Therapy Gel, Spenco Medical Corp. 2ND Skin Silicone Scar…MDA · Traditional | Medtrade Products , Ltd. | 02/14/2002SE |
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| K111578 | Coreleader Colla-Algi Fiber Model CawFRO · Traditional | 09/23/2011SE |
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| K102946 | Coreleader Colla-Pad Model CS 03030KGN · Traditional | 05/20/2011SE |
| K102943 | Coreleader Algi-Fiber Wound Dressing Model Adw 05050FRO · Traditional | 04/12/2011SE |
Questions and answers
When was Coreleader Scar-Dimmer cleared by the FDA?
Coreleader Scar-Dimmer (K111733) received a 510(k) decision of Substantially Equivalent on September 22, 2011, 93 days after the submission was received.
What is the product code of K111733?
The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.