Luma Light System

Light, Ultraviolet, Dermatological

Luma Therapeutics

The following data is part of a premarket notification filed by Luma Therapeutics with the FDA for Luma Light System.

Pre-market Notification Details

Device IDK173436
510k NumberK173436
Device Name:Luma Light System
ClassificationLight, Ultraviolet, Dermatological
Applicant Luma Therapeutics 10 Rollins Rd Suite 120 Millbrae,  CA  94030
ContactTiffini Wittwer
CorrespondentTiffini Wittwer
Luma Therapeutics 10 Rollins Rd Suite 120 Millbrae,  CA  94030
Product CodeFTC  
CFR Regulation Number878.4630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-03
Decision Date2018-01-30
Summary:summary

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