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K Number
K001772
Device Name
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
Manufacturer
TARACAN PTY. LTD.
Date Cleared
2000-07-06

(24 days)

Product Code
HQF
Regulation Number
886.4390
Type
Special
Panel
Ophthalmic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.