| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
027
|
Date of Entry 08/02/2011
|
|
FR Recognition Number
|
10-66
|
| 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 |
|
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. |
|
| 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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.3600 |
Intraocular Lens
|
Class 3
|
HQL
|
| §886.3600 |
Lens, Multifocal Intraocular
|
Class 3
|
MFK
|
| §886.4150 |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
Class 2
|
HQE
|
| §886.4390 |
Laser, Ophthalmic
|
Class 2
|
HQF
|
| §886.4392 |
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
|
Class 2
|
LXS
|
| §886.4670 |
Laser, System, Phacolysis
|
Class 2
|
MXO
|
| §886.4690 |
Photocoagulator And Accessories
|
Class 2
|
HQB
|
| N/A |
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
|
Class 3
|
LOI
|
| N/A |
Excimer Laser System
|
Class 3
|
LZS
|
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
