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K Number
K971468
Device Name
SCAR HEAL
Manufacturer
SPECIALTY SYSTEMS, INC.
Date Cleared
1997-06-10

(49 days)

Product Code
MDA
Regulation Number
878.4025
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Hypertuophie Scars
Keloid Scars

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) summary letter from the FDA regarding the "Scar Esthetique/Rejuvaskin" device. It primarily discusses the regulatory classification and substantial equivalence determination for the device, allowing it to be marketed.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or details about any MRMC or standalone studies. It is a regulatory approval letter, not a scientific study report.

§ 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.