| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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12-378
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| Standard | |
ISO 12609-1 Second edition 2021-10
Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products |
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Scope/Abstract| This document specifies general requirements for operators' 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. This document is applicable to devices intended for patient protection during ILS procedures, except for treatment in the periorbital area. For guidance on patient eye protection during ILS procedures, see ISO/TR 22463.For guidance on the use and selection of ILS eye protectors, see ISO 12609-2.This document does not apply to:- laser protectors, for which ISO 19818-1 applies;- protectors for medically prescribed applications (not occupational), e.g. eye protection for severe dry eye, tints prescribed for medical conditions;- protectors specifically intended for protection against only solar radiation and used in nonoccupational environments for which the ISO 12312 (all parts) applies;- protectors used with tanning equipment;- protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies. |
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| Extent of Recognition
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Transition Period
| FDA recognition of ISO 12609-1 First edition 2013-07-15 [Rec# 12-282] will be superseded by recognition of ISO 12609-1 Second edition 2021-10 [Rec# 12-378]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-282] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-282] will not be accepted. |
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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
|
EBZ
|
| §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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| 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. |
