AF Laser

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

ShenB Co Ltd

The following data is part of a premarket notification filed by Shenb Co Ltd with the FDA for Af Laser.

Pre-market Notification Details

Device IDK221363
510k NumberK221363
Device Name:AF Laser
ClassificationLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Applicant ShenB Co Ltd ShenB Bldg 148 Seongsui-ro Seoul,  KR 04796
ContactSunny Kang
CorrespondentConnie Hoy
Hoy And Associates 1830 Bonnie Way Sacramento,  CA  95825
Product CodePDZ  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-11
Decision Date2022-07-20

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