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Product Classification

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Device

lens,contact(rigid gas permeable)-extended wear

Regulation Description

Rigid gas permeable contact lens.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

MWL

Submission Type

PMA

Regulation Number

886.5916

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ISO 11981 Second edition 2009-07-01 Ophthalmic optics -- Contact lenses and contact lens car products -- Determination of physical compatibility of contact lens care products with contact lenses
ISO 18369-1:2006 Ophthalmic optics-Contact lenses Part 1: Vocabulary, classification system and recommendations for labeling specifications. ISO 18369-1 First edition 2006-08-05 AMENDMENT 1 2009-02-15
ISO 9394 Second edition 1998-08-15 Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of biocompatibility by ocular study using rabbit eyes
ISO 11986 Second edition 2010-11-01 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for determination of preservation uptake and release
ISO 11980 Second edition 2009-10-15 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
ISO 18369-2 First edition 2006-08-15 Ophthalmic optics -- Contact lenses -- Part 2: Tolerances
ISO 18369-3 First edition 2006-08-15 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods
ISO 18369-1 First edition 2006-08-15 Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labeling specifications
ISO 18369-4 First edition 2006-08-15 Ophthalmic optics - contact lenses - Part 4: Physicochemical properties of contact lens materials

Third Party Review

Not Third Party Eligible

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