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510(k) K170520

Device
HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
Applicant
Alcon Research, Ltd.
510(k) number
K170520
Product code
MLZ  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-22
Date received
2017-02-22
Regulation
886.4150
Classification name
Vitrectomy, Instrument Cutter
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Karen Mudd
Address
20511 Lake Forest Dr. Lake Forest CA US 92630 92630

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MLZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220030Vista Ophthalmics Vitrectomy ProbeVista Ophthalmics, LLC2022-05-04
K093305ENHANCED ULTRA VIT PROBEAlcon Research, Ltd.2010-04-02
K081681VITRECTOMY CUTTER AND ACCESSORIESAdvanced Medical Optics, Inc.2008-10-08

Legacy Summary#

summary

FDA Review#

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