Préime DermaFacial Collagen+
K-Number: K243055 · 2025-04-15
ApplicantEMA Aesthetics , Ltd.
Decision Date2025-04-15
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Préime DermaFacial Collagen+ is a medical device manufactured by EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under approval number K243055. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Préime DermaFacial Collagen+?
Préime DermaFacial Collagen+ is a medical device that received FDA 510(k) clearance on 2025-04-15. It is manufactured by EMA Aesthetics , Ltd.. The 510(k) number is K243055.
When was Préime DermaFacial Collagen+ approved by the FDA?
Préime DermaFacial Collagen+ received FDA 510(k) clearance on 2025-04-15, under approval number K243055.
What company makes Préime DermaFacial Collagen+?
Préime DermaFacial Collagen+ is manufactured by EMA Aesthetics , Ltd..
What is the FDA product code for Préime DermaFacial Collagen+?
The FDA product code for Préime DermaFacial Collagen+ is PBX.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.