Smart Laser Indirect Ophthalmoscope (LIO); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System

Powered Laser Surgical Instrument

LUMENIS LTD

The following data is part of a premarket notification filed by Lumenis Ltd with the FDA for Smart Laser Indirect Ophthalmoscope (lio); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System.

Pre-market Notification Details

Device IDK162837
510k NumberK162837
Device Name:Smart Laser Indirect Ophthalmoscope (LIO); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System
ClassificationPowered Laser Surgical Instrument
Applicant LUMENIS LTD 6 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK Yokneam,  IL 2069204
ContactNaama Jacoby
CorrespondentNaama Jacoby
LUMENIS LTD 6 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK Yokneam,  IL 2069204
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-11
Decision Date2017-02-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810096330215 K162837 000
07290109143842 K162837 000
07290109143835 K162837 000
07290109140612 K162837 000

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