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510(k) K023678

DIMISIL SCAR GEL by Aesthetic and Reconstructive Technologies, Inc. — Product Code MDA

K023678 is an FDA 510(k) premarket notification submitted by Aesthetic and Reconstructive Technologies, Inc. for the device "DIMISIL SCAR GEL". The FDA issued a decision of Substantially Equivalent on January 23, 2003. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025. Aesthetic and Reconstructive Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2003
Date Received
November 1, 2002
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 Aesthetic and Reconstructive Technologies, Inc.

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021839 — AART GLUTEAL IMPLANT (July 16, 2002)
  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K021417 — AART CHIN IMPLANT (July 2, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)

Other clearances for product code MDA

  • K112131 — NEODYNE DRESSING (September 29, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 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)
  • 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