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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 12-239: IEC 60825-1 (Second edition - 2007), i-sh 01 safety of laser products - part 1: equipment classification and requirements, interpretation sheet 1. (Radiology)

Date of Standard: 2009. 
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 DEVICE EVALUATION (ODE)
(2)OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)
Devices Affected:
Deala with the safety 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. Replaces IEC 60825 (1984) and IEC 60820 (1986). 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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