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510(k) K083718

BEAU RX SCAR CARE GEL by Beau RX Solutions, LLC — Product Code MDA

K083718 is an FDA 510(k) premarket notification submitted by Beau RX Solutions, LLC for the device "BEAU RX SCAR CARE GEL". The FDA issued a decision of Substantially Equivalent on January 26, 2009. The device falls under product code MDA (Elastomer, Silicone, For Scar Management), a Class I device regulated under 21 CFR 878.4025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2009
Date Received
December 15, 2008
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 for product code MDA

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