5 1 O(k) Summary
Curad@ Scar Therapy
General Information on the Submitter:
5 13.272 SO60
5 80 1 Mariemont Avenue
Cincinnati, Ohio 45227
Mr. Richard Taylor
General Information on Device:
Proprietary name: Curad@ Scar Therapy
Elastomer, silicone, for scar management
Scar management sheet, bandage, pad, patch, or material
Curad@ Scar Therapy is substantially equivalent to the Cutinova@thin Wound
Dressing (K94-4581) and the Mepiform Adherent Silicone Dressing for Scar Care (K97-
Description of the Device:
Curad@ Scar Therapy is a semi-occlusive, flexible pad for the management of
hypertrophic scars resulting from burns, surgery, or injuries, after complete healing.
The device is also intended for management of keloid scars. It may be used as a
prophylactic therapy on closed wounds which may prevent hypertrophic and keloid
scarring. It is intended for over-the-counter use.
Curad@ Scar Therapy consists of an adhesive aliphatic polyurethane matrix.
Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a
waterproof polyurethane film that is permeable to oxygen and water vapor.
The Curad@ Scar Therapy pads are individually sealed in envelopes and
packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to
be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment
should consist of at least 12 hours a day for at least eight weeks.
Curad@ Scar Therapy is intended for the management of hypertrophic and
keloid scars. It may be used as a prophylactic therapy on closed wounds which may
prevent hypertrophic and keloid scarring.
Summary of Substantial Equivalence
In terms of its composition or technological characteristics, Curad@Scar Therapy
is identical, and therefore