Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-72: ISO 15004-1 First edition 2006-06-01, Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments. (Ophthalmic)

Date of Standard: 2006.

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:

All ophthalmic instruments

Processes Affected:

510(k), PMA, IDE, PDP, HDE, Design Control Input

Type of Standard:

Horizontal, International

Extent of Recognition:

Complete standard and any annexes

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§874.4350	Source, Carrier, Fiberoptic Light	Class 1	EQH

Regulation Number	Device Name	Device Class	Product Code
§876.1500	Endoilluminator	Class 2	MPA
§876.1500	Endoilluminator, Reprocessed	Class 2	NKZ

Regulation Number	Device Name	Device Class	Product Code
§886.1120	Camera, Ophthalmic, Ac-Powered	Class 2	HKI

Regulation Number	Device Name	Device Class	Product Code
§886.1570	Ophthalmoscope, Ac-Powered	Class 2	HLI
§886.1570	Ophthalmoscope, Battery-Powered	Class 2	HLJ
§886.1570	Ophthalmoscope,Laser,Scanning	Class 2	MYC

Regulation Number	Device Name	Device Class	Product Code
§886.1780	Retinoscope, Ac-Powered	Class 2	HKL
§886.1780	Retinoscope, Battery-Powered	Class 1	HKM

Regulation Number	Device Name	Device Class	Product Code
§886.1850	Biomicroscope, Slit-Lamp, Ac-Powered	Class 2	HJO
§886.1850	Device,Analysis,Anterior Segment	Class 2	MXK
§886.1850	Microscope, Specular	Class 2	NQE

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