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Recognized Consensus Standards

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Recognition List Number: 029 FR Publication Date: 08/20/2012 

Part B: Supplementary Information

Recognition Number 12-249: IEC 62471 First edition 2006-07, photobiological safety of lamps and lamp systems. (Radiology)

Date of Standard: 2006. 
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)
(2)OFFICE OF DEVICE EVALUATION (ODE)
(3)OFFICE OF COMPLIANCE (OC)
(4)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
Devices Affected:
All devices and products that emit non-coherent (i.e., non-laser) optical radiation
Processes Affected:
510(k), IDE, PMA, PDP, HDE, Design Control Input
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard with the following notes:

*Clause 6 Lamp Classification: Risk group classification defined in this clause do not correspond to the FDA's Medical Device Classification per 21 CFR 860 Medical Device Classification Procedures. They also have no bearing on any reporting requirements under the Electronic Product Radiation Control Provisions, Section 531 through 542 of the Federal Food, Drug, and Cosmetic Act.

*Subclause 4.1 Exposure limits - General: Spectral measurements for FDA-regulated products should be performed regardless of level of luminance of the source.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§878.4810 Laser Assisted Lipolysis Class 2 ORK
§878.4810 Laser, Benign Prostatic Hyperplasia Class 2 OEL
§878.4810 Laser, Cellulite Appearance Class 2 OYW
§878.4810 Laser, Dental, Soft Tissue Class 2 NVK
§878.4810 Light Based Over The Counter Wrinkle Reduction Class 2 OHS
§878.4810 Light Based Over-The-Counter Hair Removal Class 2 OHT
§878.4810 Massager, Vacuum, Light Induced Heating Class 2 NUV
§878.4810 Neurosurgical Laser With Mr Thermography Class 2 ONO
§878.4810 Over-The-Counter Powered Light Based Laser For Acne Class 2 OLP
§878.4810 Powered Laser Surgical Instrument Class 2 GEX
§878.4810 Powered Laser Surgical Instrument With Microbeam\Fractional Output Class 2 ONG
§878.4810 Powered Light Based Non-Laser Surgical Instrument Class 2 ONE
§878.4810 Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Class 2 ONF
Relevant Guidance:
21 CFR 860 Medical Device Classification Procedures, 2011

FD&C Act Chapter V Drugs and Devices, Subchapter C Electronic Product Radiation Control (21 U.S.C. 360hh - 360ss), 2006

21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology, 2011.
FDA Technical Contacts:
 Sharon A. Miller
  FDA/CDRH/OCER
  10903 New Hampshire Avenue Building 66, Room 4661
  Silver Spring MD 20993
  301/796-2471
  email: sharona.miller@fda.hhs.gov
 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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