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Product Classification

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Device

lens, multifocal intraocular

Regulation Description

Intraocular lens.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

MFK

Submission Type

PMA

Regulation Number

886.3600

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ISO TR 22979 First edition 2006-02-01 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation or intraocular lens design modifications
ISO 11979-8 Second edition 2006-07-01 Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements
ISO 11979-7/Amendment 1:2012 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations
ISO 11979-8/Amd 1:2011 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
ISO 11979-3 Second edition 2006-05-01 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods
ISO 11979-5 Second edition 2006-06-01 Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility
ISO 11979-6 Second edition 2007-07-15 Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability
ANSI Z80.12-2007 American National Standard for Ophthalmics - Multifocal Intraocular Lenses
ANSI
ISO 10936-2 Second edition 2010-01-15 Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
ISO 15004-1 First edition 2006-06-01 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
ISO 11979-1 Second edition 2006-07-15 Ophthalmic implants -- Intraocular lenses - Part 1: Vocabulary

Third Party Review

Not Third Party Eligible

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