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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 12-242
Standard
IEC 60601-2-57 Edition 1.0 2011-01
Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Scope/Abstract
This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).

This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.

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
§890.5500 Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Class 2 NHN
§878.5400 Fat Reducing Low Level Laser Class 2 OLI
§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
Unclassified System, Laser, Photodynamic Therapy Class 3 MVF
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
FDA Technical Contact
 Richard P. Felten
  FDA/OMPT/CDRH/ODE/DSD/GSDB1/
  301-796-6392
  richard.felten@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
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