Illumiflow 148 Laser Cap

Laser, Comb, Hair

EGlobal, LLC

The following data is part of a premarket notification filed by Eglobal, Llc with the FDA for Illumiflow 148 Laser Cap.

Pre-market Notification Details

Device IDK173843
510k NumberK173843
Device Name:Illumiflow 148 Laser Cap
ClassificationLaser, Comb, Hair
Applicant EGlobal, LLC 10115 E Bell Rd Suite 107 Scottsdale,  AZ  85260
ContactWayne De Stefano
CorrespondentLiza Burns
Liza Burns And Associates 6469 G Kawaihau Road Kapaa,  HI  96746
Product CodeOAP  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-18
Decision Date2018-01-26
Summary:summary

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