K Number
K111168
Date Cleared
2011-12-13

(232 days)

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

Under the supervision of a healthcare professional, Precision Skin Emulsion is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Precision Skin Emulsion also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Device Description

Precision Skin Emulsion is a non-sterile, off-white, low odor, fragrance free, topical product. The Precision Skin Emulsion forms a physical barrier that helps to maintain a moist wound and skin environment. This is a prescription device.

AI/ML Overview

I am sorry but I did not find any information about acceptance criteria or a study that proves the device meets the acceptance criteria. Thus, I cannot construct a response based on the request.

N/A