MMD Tip

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 Mmd Tip.

Pre-market Notification Details

Device IDK181480
510k NumberK181480
Device Name:MMD Tip
ClassificationPowered Laser Surgical Instrument
Applicant Strata Skin Sciences, Inc. 100 Lakeside Dr. Suite 100 Horsham,  PA  19044
ContactShmuel Gov
CorrespondentPaul Dryden
Strata Skin Sciences, Inc. % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg,  FL  33704
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-05
Decision Date2018-08-01
Summary:summary

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