| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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|
FR Recognition Number
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10-111
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| Standard | |
ISO 11981 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses |
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Scope/Abstract| This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible. |
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| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.5916 |
Lens, Contact (Other Material) - Daily
|
Class 2
|
HQD
|
| §886.5916 |
Lens, Contact (Orthokeratology)
|
Class 2
|
MUW
|
| §886.5916 |
Lens, Contact (Rigid Gas Permeable), Extended Wear
|
Class 3
|
MWL
|
| §886.5916 |
Lens, Contact, Orthokeratology, Overnight
|
Class 3
|
NUU
|
| §886.5918 |
Products, Contact Lens Care, Rigid Gas Permeable
|
Class 2
|
MRC
|
| §886.5925 |
Lenses, Soft Contact, Daily Wear
|
Class 2
|
LPL
|
| §886.5925 |
Lenses, Soft Contact, Extended Wear
|
Class 3
|
LPM
|
| §886.5925 |
Lens, Contact, (Disposable)
|
Class 2
|
MVN
|
| §886.5925 |
System, In-Office Tinting, Contact Lenses
|
Class 2
|
MZD
|
| §886.5925 |
Lens, Contact, For Color Vision Deficiency
|
Class 2
|
NCZ
|
| §886.5925 |
Lens, Contact, For Reading Discomfort
|
Class 2
|
NIC
|
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Battery-Powered
|
Class 2
|
HRC
|
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Ac-Powered
|
Class 2
|
HRD
|
| §886.5928 |
Accessories, Soft Lens Products
|
Class 2
|
LPN
|
| §886.5928 |
Case, Contact Lens
|
Class 2
|
LRX
|
| §886.5928 |
Accessories, Solution, Ultrasonic Cleaners For Lenses
|
Class 2
|
LYL
|
|
Relevant FDA Guidance and/or Supportive Publications*
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 1997.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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