(131 days)
For the management of hypertrophic or keloid scars.
SCAR CARE™ is intended for use in the management of hypertrophic and keloid scars.
SCAR CARE™ is a device composed of an outer shell consisting of medical grade silicone sheets adherent to each other with a sealed internal component filled with medical grade silicone oil. It is a soft, semi-transparent rubbery device.
This document is a 510(k) summary for the SCAR CARE™ device and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The provided text focuses on:
- The FDA's 510(k) clearance letter for SCAR CARE™.
- General information about the regulatory process for medical devices.
- A 510(k) summary for SCAR CARE™ detailing its trade name, common name, predicate device (TopiGel™ Gel Sheeting), description, and intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them, as it is not present in 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.