Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-59: ISO 11980 Second edition 2009-10-15, Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations. (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: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
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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 |
| |
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 |
| |
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: |
| Denise Hampton, Ph.D |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2252 |
| Silver Spring MD 20993 |
| 301/796-6860 |
| Email: denise.hampton@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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