K-number	K243072
Device name	Préime DermaFacial (MicroT)
Applicant	EMA Aesthetics , Ltd.
Product code	NFO
Device class	Class II
Decision date	Apr 1, 2025
Decision	Substantially Equivalent
Regulation	882.5890

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Préime DermaFacial with MicroT Applicator is a transcutaneous electrical nerve stimulator intended to stimulate facial tissues for aesthetic purposes in the face. It is regulated as a Class II device under 21 CFR 882.5890.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence was determined but does not provide the technical reasoning, comparison to predicate devices, or performance data supporting that determination. The enclosure referenced in the letter is not included in this document.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Préime DermaFacial (MicroT)

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