PicoWay Laser System

Powered Laser Surgical Instrument

SYNERON CANDELA CORPORATION

The following data is part of a premarket notification filed by Syneron Candela Corporation with the FDA for Picoway Laser System.

Pre-market Notification Details

Device IDK153527
510k NumberK153527
Device Name:PicoWay Laser System
ClassificationPowered Laser Surgical Instrument
Applicant SYNERON CANDELA CORPORATION 530 BOSTON POST ROAD Wayland,  MA  01778
ContactRuthie Amir
CorrespondentJanice M. Hogan
HOGAN LOVELLS US LLP 1835 MARKET STREET 29TH FLOOR Philadelphia,  PA  19103
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-09
Decision Date2016-03-02
Summary:summary

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