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K Number
K243055
Device Name
Préime DermaFacial Collagen+
Manufacturer
EMA Aesthetics, LTD
Date Cleared
2025-04-15

(200 days)

Product Code
PBX
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Préime DermaFacial with Collagen+ Applicator is intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, temporarily improve the appearance of cellulite.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided FDA 510(k) Clearance Letter for the "Préime DermaFacial Collagen+" device does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The letter is a formal notification of substantial equivalence for a medical device (an electrosurgical cutting and coagulation device) based on its intended use to relieve minor muscle aches and pain, muscle spasms, improve local blood circulation, and temporarily improve the appearance of cellulite.

It details:

  • The device name and regulation information.
  • The legal basis for its clearance (substantial equivalence to predicate devices).
  • Applicable regulations and requirements (e.g., general controls, Quality System regulation, UDI Rule).
  • Contact information for FDA.
  • The specific Indications for Use.

It does NOT include:

  • Any performance specifications or acceptance criteria (e.g., sensitivity, specificity, accuracy, or any performance metrics related to its stated indications).
  • Details of any clinical or non-clinical studies conducted to demonstrate its performance against such criteria.
  • Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or any aspects of a statistical study design.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text, as this information is not present. This type of detail is typically found in a separate study report or a more comprehensive FDA submission document, not within the clearance letter itself.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.