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K Number
K111493
Device Name
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI
Manufacturer
NIDEK CO., LTD.
Date Cleared
2011-07-27

(57 days)

Product Code
HQB
Regulation Number
886.4690
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4690 Ophthalmic photocoagulator.

(a)
Identification. An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.(b)
Classification. Class II.