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Product Classification

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Device

lens,intraocular,accommodative

Regulation Description

Intraocular lens.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

NAA

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

11979-2 First edition 1999-12-15/ ISO 11979-2:1999 TECHNICAL CORRIGENDUM 1 Ophthalmic implants - Intraocular lenses -- Part 2: Optical properties and test methods
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
ISO 11979-8 Second edition 2006-07-01 Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements
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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