(55 days)
This device may be used for the management of Keloid and hypertrophic scars occurring as a result of traumatic injury or surgical procedures. This device is not intended to be used on open wounds. This device is intended for over-the-counter use.
Kelocote Silicone Sheeting
This document is a 510(k) clearance letter from the FDA for the "Kelocote Silicone Sheeting" device. It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The letter primarily addresses the regulatory approval of the device based on substantial equivalence, but it does not detail performance metrics or studies specific to meeting acceptance criteria.
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.