K-number	K243445
Device name	Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Applicant	Bios S.R.L.
Product code	GEX
Device class	Class II
Decision date	Dec 30, 2024
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Splendor X is a multi-wavelength laser surgical instrument available in four configurations: Alex (755nm Alexandrite), Alex2 (755nm), Nd:YAG (1064nm), and Alex+Nd:YAG (combined 755nm and 1064nm). It is intended for hair removal and reduction, treatment of benign pigmented and vascular lesions, coagulation of soft tissue, scar treatment, wrinkle reduction, and temporary improvement of onychomycosis. The device is cleared for use on all skin types (Fitzpatrick I-VI) including tanned skin.

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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Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

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