Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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036
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Date of Entry 07/09/2014
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FR Recognition Number
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12-283
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Standard | |
ISO 12609-2 First edition 2013-07-15 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use |
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Scope/AbstractISO 12609-2:2013 gives guidance and information to users, manufacturers, suppliers, and safety advisors on the selection and use of eye protectors for intense light source (ILS) equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.
ISO 12609-2:2013 provides guidance on selection of an eye protector expected to cope with the majority of applications and a more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.6070 |
Activator, Ultraviolet, For Polymerization
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Class 2
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EBZ
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§886.4750 |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
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Class 1
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HOY
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§886.4750 |
Collagen Corneal Shield
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Class 1
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MOE
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§892.6500 |
Shield, Eye, Radiological
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Class 1
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IWS
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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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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. |