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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 051 Date of Entry 01/14/2019 
FR Recognition Number 12-321
Standard
ANSI IES  RP-27.3-17
Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling
Scope/Abstract
This standard covers the classification, labeling and informational requirements for lamps that emit optical radiation in the wavelength range from 200 nm to 3,000 nm, with exception for LED diodes used in optical fiber communication systems and for lasers. Lamps included are incandescent filament lamps including tungsten halogen types and incandescent heating sources, low pressure discharge lamps, high intensity discharge (HID) lamps, short arc lamps, carbon arcs, electroluminescent lamps, lightemitting diodes (LEDs), organic light emitting diodes(OLEDs) and laser-driven broadband sources. For the purposes of this document, induction lighting is classified under fluorescent lamps and plasma lighting is classified under HID lamps. Federal mandatory requirements for lamps subject to specific Federal Regulations take precedence over requirements included in this consensus standard.
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
21 CFR 860 Medical Device Classification Procedures
FD&C Act Chapter V Drugs and Devices, Subchapter C Electronic Product Radiation Control (21 U.S.C. 3
Relevant FDA Guidance and/or Supportive Publications*
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
  CDRH/OPEQ/OIDRH/DRH/MREPB
  240-402-1313
  Pejman.Ghassemi@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
IES Illuminating Engineering Society https://www.ies.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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