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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.

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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.

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The Préime DermaFacial with MicroT Applicator is intended to stimulate facial tissues for aesthetic purposes in the face.

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I apologize, but the provided FDA 510(k) clearance letter for the Préime DermaFacial (MicroT) device does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

This type of FDA clearance letter primarily states that the device has been found substantially equivalent to a predicate device and outlines regulatory obligations. It does not typically detail the specific performance studies, acceptance criteria, or expert qualifications that were submitted as part of the 510(k) application.

To answer your questions, I would need to access the full 510(k) submission document or a summary of safety and effectiveness, which is not included in the provided text.

Therefore, I cannot provide the requested table and detailed information based solely on this document.

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