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510(k) K111733

CORELEADER SCAR-DIMMER by Coreleader Biotech Co., Ltd. — Product Code MDA

K111733 is an FDA 510(k) premarket notification submitted by Coreleader Biotech Co., Ltd. for the device "CORELEADER SCAR-DIMMER". The FDA issued a decision of Substantially Equivalent on September 22, 2011. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Coreleader Biotech Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
June 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone, For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type

Other clearances by Coreleader Biotech Co., Ltd.

  • K151204 — HEMO-Bandage (July 31, 2015)
  • K141382 — BIOS KING BIOCELLULOSE FILM (February 10, 2015)
  • K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (June 6, 2013)
  • K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW (September 23, 2011)
  • K102944 — CORELEADER HEMO-PAD MODEL CPII 02030 (September 7, 2011)
  • K102942 — CORELEADER ALGIPLASTER MODEL AP 050501 (June 22, 2011)
  • K102946 — CORELEADER COLLA-PAD MODEL CS 03030 (May 20, 2011)
  • K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (April 12, 2011)

Other clearances for product code MDA

  • K112131 — NEODYNE DRESSING (September 29, 2011)
  • K083718 — BEAU RX SCAR CARE GEL (January 26, 2009)
  • K053481 — KELO-COTE SPRAY (April 14, 2006)
  • K041704 — NEWGEL AND NEWGEL PLUS E (October 17, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K023136 — OLEEVA FABRIC (October 16, 2002)
  • K014036 — MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILIC (February 14, 2002)

FDA data resources