Auxo A300, A150 And APod

Laser, Comb, Hair

Auxo Hair, LLC

The following data is part of a premarket notification filed by Auxo Hair, Llc with the FDA for Auxo A300, A150 And Apod.

Pre-market Notification Details

Device IDK220543
510k NumberK220543
Device Name:Auxo A300, A150 And APod
ClassificationLaser, Comb, Hair
Applicant Auxo Hair, LLC 16300 SW 101 Ave Miami,  FL  33157
ContactPatricia Schnoor
CorrespondentPatricia Schnoor
Auxo Hair, LLC 16300 SW 101 Ave Miami,  FL  33157
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-25
Decision Date2022-04-20

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