SPECTRA LASER SYSTEM

Powered Laser Surgical Instrument

LUTRONIC CORPORATION

The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Spectra Laser System.

Pre-market Notification Details

Device IDK103455
510k NumberK103455
Device Name:SPECTRA LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant LUTRONIC CORPORATION 51 EVERETT DRIVE, UNIT A-50 Princeton Junction,  NJ  08550
ContactJhung Won Vojir
CorrespondentJhung Won Vojir
LUTRONIC CORPORATION 51 EVERETT DRIVE, UNIT A-50 Princeton Junction,  NJ  08550
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-23
Decision Date2011-04-28
Summary:summary

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