• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 028 FR 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 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)
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
§876.1500 Endoilluminator Class 2 MPA
§876.1500 Endoilluminator, Reprocessed Class 2 NKZ
§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
§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
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
-
-