Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links

Product Classification

-

Back To Search Results

Device

lenses, soft contact, extended wear

Regulation Description

Soft (hydrophilic) contact lens.

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

LPM

Submission Type

PMA

Regulation Number

886.5925

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

-

-