Recognized Consensus Standards

Recognition List Number: 027 Publication Date: 08/02/2011

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-66: ISO 10936-2 Second edition 2010-01-15, Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery. (Ophthalmic)

Date of Standard: 2010.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

OFFICE OF DEVICE EVALUATION (ODE)

Devices Affected:

Operation Microscopes

Processes Affected:

PMA, IDE, PDP, HDE, Design Control Input

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard and any annexes

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Excimer Laser System	Class 3	LZS
Unclassified	Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary	Class 3	LOI

Regulation Number	Device Name	Device Class	Product Code
§886.3600	Intraocular Lens	Class 3	HQL
§886.3600	Lens, Multifocal Intraocular	Class 3	MFK

Regulation Number	Device Name	Device Class	Product Code
§886.4150	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Class 2	HQE

Regulation Number	Device Name	Device Class	Product Code
§886.4390	Laser, Ophthalmic	Class 2	HQF

Regulation Number	Device Name	Device Class	Product Code
§886.4392	Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla	Class 2	LXS

Regulation Number	Device Name	Device Class	Product Code
§886.4670	Laser,System,Phacolysis	Class 2	MXO

Regulation Number	Device Name	Device Class	Product Code
§886.4690	Photocoagulator And Accessories	Class 2	HQB