Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)

Laser, Comb, Hair

Xtrallux, LLC

The following data is part of a premarket notification filed by Xtrallux, Llc with the FDA for Xtrallux Alpha (xa136r-usa), Xtrallux Super Plus (xs276r-usa/xs276l-usa), Xtrallux Turbo Pro (xp316r-usa), Xtrallux Extreme Rx (xr352r-usa).

Pre-market Notification Details

Device IDK222364
510k NumberK222364
Device Name:Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
ClassificationLaser, Comb, Hair
Applicant Xtrallux, LLC 7260 NW 58th Street Miami,  FL  33166
ContactCarlos Piña
CorrespondentFreeman Anike
RQM+ 2251 San Diego Avenue Suite B-257 San Diego,  CA  92110
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-04
Decision Date2022-11-16

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