Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
A to Z Index
Follow FDA
FDA Voice Blog
Enter Search terms
Most Popular Searches
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Product Classification
FDA Home
Medical Devices
Databases
-
New Search
Back To Search Results
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
-
-