Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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10-124
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Standard | |
ISO 11979-1 Fourth edition 2018-11 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
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Scope/AbstractThis document defines terms applicable to intraocular lenses, and to the methods used to evaluate them.
NOTE Terms are listed in the alphabetical order of the English terms in the English version of this document. |
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Extent of Recognition
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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 |
§886.3600 |
Intraocular Lens
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Class 3
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HQL
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§886.3600 |
Lens, Multifocal Intraocular
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Class 3
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MFK
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§886.3600 |
Lens, Intraocular, Toric Optics
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Class 3
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MJP
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§886.3600 |
Lens, Intraocular, Accommodative
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Class 3
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NAA
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§886.3600 |
Lens, Iris Reconstruction
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Class 3
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NIZ
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§886.3600 |
Phakic Toric Intraocular Lens
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Class 3
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QCB
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N/A |
Lens, Intraocular, Phakic |
Class 3
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MTA
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Relevant FDA Guidance and/or Supportive Publications*
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 Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |