IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2

Powered Laser Surgical Instrument

CYDEN LIMITED

The following data is part of a premarket notification filed by Cyden Limited with the FDA for Ipulse, Quadra Q4 Platinum Series, Model(s) 1200+series 2, 1300 Series 2, Q4 Series 2.

Pre-market Notification Details

Device IDK071883
510k NumberK071883
Device Name:IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
ClassificationPowered Laser Surgical Instrument
Applicant CYDEN LIMITED TECHNIUM 1, KINGS ROAD Swansea, Wales,  GB Sa1 8ph
ContactMichael Kiernan
CorrespondentMichael Kiernan
CYDEN LIMITED TECHNIUM 1, KINGS ROAD Swansea, Wales,  GB Sa1 8ph
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-09
Decision Date2008-01-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.