K-number	K243055
Device name	Préime DermaFacial Collagen+
Applicant	EMA Aesthetics , Ltd.
Product code	PBX
Device class	Class II
Decision date	Apr 15, 2025
Decision	Substantially Equivalent
Regulation	878.4400

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Préime DermaFacial Collagen+ is an electrosurgical device intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, and temporarily improve the appearance of cellulite. It is classified as a Class II electrosurgical cutting and coagulation device.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Préime DermaFacial Collagen+

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