| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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027
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Date of Entry 08/02/2011
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FR Recognition Number
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10-66
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| Standard | |
ISO 10936-2 Second edition 2010-01-15
Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery |
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Scope/Abstract| This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery. |
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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 |
| §886.4392 |
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
Class 2 |
LXS |
| §886.3600 |
Intraocular Lens |
Class 3 |
HQL |
| §886.3600 |
Lens, Multifocal Intraocular |
Class 3 |
MFK |
| §886.4390 |
Laser, Ophthalmic |
Class 2 |
HQF |
| §886.4670 |
Laser, System, Phacolysis |
Class 2 |
MXO |
| §886.4150 |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
Class 2 |
HQE |
| §886.4690 |
Photocoagulator And Accessories |
Class 2 |
HQB |
| Unclassified |
Excimer Laser System |
Class 3 |
LZS |
| Unclassified |
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
Class 3 |
LOI |
|
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. |
