(126 days)
To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.
Not Found
This document is a 510(k) clearance letter from the FDA for the LMI Scar Management device, indicating it has been found substantially equivalent to a predicate device. It does not contain information on acceptance criteria or a study proving device performance against such criteria. The letter primarily addresses regulatory approval based on substantial equivalence, not a detailed performance study. Therefore, I cannot provide the requested information from the given text.
§ 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.