Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) 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. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243055.

When did Préime DermaFacial Collagen+ receive FDA 510(k) clearance?

Préime DermaFacial Collagen+ received FDA 510(k) clearance on 2025-04-15, under 510(k) number K243055.

Who is the listed applicant for Préime DermaFacial Collagen+?

The FDA 510(k) record lists EMA Aesthetics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Préime DermaFacial Collagen+?

The FDA product code for Préime DermaFacial Collagen+ is PBX.

Other records listing EMA Aesthetics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243072Préime DermaFacial (MicroT)

Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑