XTRAC Momentum Excimer Laser System

Powered Laser Surgical Instrument

Strata Skin Sciences, Inc.

The following data is part of a premarket notification filed by Strata Skin Sciences, Inc. with the FDA for Xtrac Momentum Excimer Laser System.

Pre-market Notification Details

Device IDK193478
510k NumberK193478
Device Name:XTRAC Momentum Excimer Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Strata Skin Sciences, Inc. 5 Walnut Grove Drive, Suite 140 Horsham,  PA  19044
ContactChuck Mierkiewicz
CorrespondentPaul Dryden
Strata Skin Sciences, Inc. C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-01-14

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