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Recognized Consensus Standards

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Recognition List Number: 026 FR Publication Date: 03/18/2011 

Part B: Supplementary Information

Recognition Number 12-220: IEC 60825-1 (Second edition - 2007), safety of laser products - part 1: equipment classification and requirements corrigendum 1. (Radiology)

Date of Standard: 2008. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)
DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP)
(2)OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
(3)OFFICE OF DEVICE EVALUATION (ODE)
(4)OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
IEC 60825-1 Ed. 2.0:2007 Corrigendum 1:2008 deals with the safety of laser products, covers laser radiation in the wavelength range 180 nm to 1 mm, indicates safe working levels of laser radiation, and introduces a system of classification of lasers and laser products according to their degree of hazard. It replaces IEC 60825 (1984) and IEC 60820 (1986), and it has the status of a group safety publication in accordance with IEC Guide 104.
Processes Affected:
510(k), PMA, IDE, Initial reports
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Device, Angioplasty, Laser, Coronary Class 3 LPC
Unclassified Device. Laser Peripheral Angioplasty Class 3 LWX
Unclassified Excimer Laser System Class 3 LZS
Unclassified Laser For Gastro-Urology Use   LNK
Unclassified Laser, Dental   LYB
Unclassified Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary Class 3 LOI
Unclassified Laser, Neurosurgical Class 3 LKW
Unclassified Laser, Neurosurgical, Argon Class 3 LLF
Unclassified System, Laser, Fiber Optic, Photodynamic Therapy Class 3 MVG
Unclassified System, Laser, Photodynamic Therapy Class 3 MVF
Unclassified System, Laser, Transmyocardial Revascularization Class 3 MNO
§874.4490 Laser, Microsurgical Argon, For Use In Otology Class 2 LXR
§874.4490 Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology Class 2 LMS
§874.4500 Laser, Ent Microsurgical Carbon-Dioxide Class 2 EWG
§874.4500 Laser, Neodymium:Yag, Pulmonary Surgery Class 2 LLO
§878.4810 Powered Laser Surgical Instrument Class 2 GEX
§884.4550 Laser, Neodymium:Yag For Gynecologic Use Class 2 LLW
§884.4550 Laser, Surgical, Gynecologic Class 2 HHR
§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:
 Richard P. Felten
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1436
  Silver Spring MD 20993
  301/796-6392
  email: richard.felten@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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