ID-500 IRestore Hair Growth System

Laser, Comb, Hair

Freedom Laser Therapy, Inc.

The following data is part of a premarket notification filed by Freedom Laser Therapy, Inc. with the FDA for Id-500 Irestore Hair Growth System.

Pre-market Notification Details

Device IDK213094
510k NumberK213094
Device Name:ID-500 IRestore Hair Growth System
ClassificationLaser, Comb, Hair
Applicant Freedom Laser Therapy, Inc. 16782 Von Karman Avenue, Unit 15 Irvine,  CA  92606
ContactWei-chih (kevin) Chen
CorrespondentSharon Chen
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-24
Decision Date2021-12-22

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