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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 019 FR Publication Date: 12/19/2007 

Part B: Supplementary Information

Recognition Number 10-51: ISO 15004-2 First edition 2007-02-15, ophthalmic instruments - fundamental requirements and test methods part 2: light hazard protection. (Ophthalmic)

Date of Standard: 2007. 
Address of Standards Development 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)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
All ophthalmic instruments that direct optical radiation at or into the eye including but not limited to: Direct Opthalmoscopes, AC and DC Powered, Indirect, Opthalmoscopes, AC and DC Powerd, Slit Lamps, Fundus Cameras, Specular Microscopes, Endoilluminators, Operation Microscopes for ocular surgery.
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Horizontal
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§878.4700 Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class 1 HRM
§878.4700 Microscope, Operating, Non-Electric, Ophthalmic Class 1 HRB
§878.4700 Microscope, Surgical, General & Plastic Surgery Class 1 FSO
§886.1120 Camera, Ophthalmic, Ac-Powered Class 2 HKI
§886.1570 Ophthalmoscope, Ac-Powered Class 2 HLI
§886.1570 Ophthalmoscope, Battery-Powered Class 2 HLJ
§886.1570 Ophthalmoscope,Laser,Scanning Class 2 MYC
§886.1780 Retinoscope, Ac-Powered Class 2 HKL
§886.1780 Retinoscope, Battery-Powered Class 1 HKM
§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
FDA Technical Contact:
 Dexiu Shi
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2246
  Silver Spring MD 20993
  301/796-6860
  email: dexiu.shi@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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