ID-510 IRestore Elite

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-510 Irestore Elite.

Pre-market Notification Details

Device IDK222081
510k NumberK222081
Device Name:ID-510 IRestore Elite
ClassificationLaser, Comb, Hair
Applicant Freedom Laser Therapy, Inc. 16782 Von Karman Avenue, Unit 15 Irvine,  CA  92606
ContactWei-Chih 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 Received2022-07-15
Decision Date2022-10-13

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