Recognition List Number: 019 Publication Date: 12/19/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-54: ISO 18369-4 First edition 2006-08-15, Ophthalmic optics - contact lenses - Part 4: Physicochemical properties of contact lens materials. (Ophthalmic)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete standard and any annexes with the following exceptions:
1. Soxhlet extractions of some lens materials may require longer than 4 hours for exhaustive extractions of some materials. This standard requires that use of water and one organic solvent. Depending on the organic solvent chosen, some components may be missed. For example, an organic solvent which is too polar may not adequately extract some very nonpolar additives.
2.The Oxygen permeability of very high Dk materials may not be consistently measured by the polarographic method using 20.9% oxygen. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.5916 |
Lens, Contact (Orthokeratology) |
Class 2 |
MUW |
| §886.5916 |
Lens, Contact (Other Material) - Daily |
Class 2 |
HQD |
| §886.5916 |
Lens, Contact, Orthokeratology, Overnight |
Class 3 |
NUU |
| §886.5916 |
Lens,Contact(Rigid Gas Permeable)-Extended Wear |
Class 3 |
MWL |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.5925 |
Lens, Contact, (Disposable) |
Class 2 |
MVN |
| §886.5925 |
Lens, Contact, For Color Vision Deficiency |
Class 2 |
NCZ |
| §886.5925 |
Lens, Contact, For Reading Discomfort |
Class 2 |
NIC |
| §886.5925 |
Lenses, Soft Contact, Daily Wear |
Class 2 |
LPL |
| §886.5925 |
Lenses, Soft Contact, Extended Wear |
Class 3 |
LPM |
| §886.5925 |
System,In-Office Tinting,Contact Lenses |
Class 2 |
MZD |
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| Relevant Guidance: |
| Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994 |
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| FDA Technical Contact: |
| Joseph C. Hutter |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2458 |
| Silver Spring MD 20993 |
| 301/796-6499 |
| Email: joseph.hutter@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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