Photonica Professional

Fat Reducing Low Level Laser

Ward Photonics LLC

The following data is part of a premarket notification filed by Ward Photonics Llc with the FDA for Photonica Professional.

Pre-market Notification Details

Device IDK160880
510k NumberK160880
Device Name:Photonica Professional
ClassificationFat Reducing Low Level Laser
Applicant Ward Photonics LLC 1980 N Atlantic Avenue Cocoa Beach,  FL  32931
ContactTerry Ward
CorrespondentJeff Brown
Alliance Lifescience Partnerships, LLC 1260 Bell View Circle Sandy,  UT  84094
Product CodeOLI  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-30
Decision Date2016-09-23
Summary:summary

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