Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-60: 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. (Ophthalmic)
Date of Standard: 2009. |
| 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: |
| Contact lenses and contact lens care products |
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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 modifications:
For contact lenses that are surface treated, the integrity of the surface treatment should be verified after cycling using an appropriate test method. Possible tests include but may not be limited to contact angle, dye penetration, x-ray photospectroscopy, ion permeability. |
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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 |
| §886.5918 |
Products, Contact Lens Care, Rigid Gas Permeable |
Class 2 |
MRC |
| |
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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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.5928 |
Accessories, Soft Lens Products |
Class 2 |
LPN |
| §886.5928 |
Accessories, Solution, Ultrasonic Cleaners For Lenses |
Class 2 |
LYL |
| §886.5928 |
Case, Contact Lens |
Class 2 |
LRX |
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Ac-Powered |
Class 2 |
HRD |
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Battery-Powered |
Class 2 |
HRC |
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| Relevant Guidance: |
Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. Issued May 1994
Guidance for Industry Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products. Issued May 1, 1997 |
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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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