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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Entry 08/20/2012 
FR Recognition Number 12-249
IEC  62471 First edition 2006-07
Photobiological safety of lamps and lamp systems
This International Standard gives guidance for evaluating the photobiological safety of lamps and lamp systems including luminaires. Specifically it specifies the exposure limits, reference measurement technique and classification scheme for the evaluation and control of photobiological hazards from all electrically powered incoherent broadband sources of optical radiation, including LEDs but excluding lasers, in the wavelength range from 200 nm through 3000 nm.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§878.4810 Powered Laser Surgical Instrument Class 2 GEX
§878.4810 Massager, Vacuum, Light Induced Heating Class 2 NUV
§878.4810 Laser, Dental, Soft Tissue Class 2 NVK
§878.4810 Laser, Benign Prostatic Hyperplasia Class 2 OEL
§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 Over-The-Counter Powered Light Based Laser For Acne Class 2 OLP
§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
§878.4810 Powered Laser Surgical Instrument With Microbeam\Fractional Output Class 2 ONG
§878.4810 Neurosurgical Laser With Mr Thermography Class 2 ONO
§878.4810 Laser Assisted Lipolysis Class 2 ORK
§878.4810 Laser, Cellulite Appearance Class 2 OYW
Relevant FDA Guidance and/or Supportive Publications*
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.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Pejman Ghassemi
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.