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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 043 Date of Entry 06/27/2016 
FR Recognition Number 12-297
ANSI IES  RP-27.1-2015
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
The purpose of these standards is to inform the public and original equipment manufacturers (OEMs) about potential radiation hazards that may be associated with various lamps and lamp systems. It is also the purpose of these standards to provide guidance, advice, and standard methods for evaluating and informing the user, both the public and the OEM, about the potential optical radiation hazards that may be associated with these products.

This Recommended Practice covers the evaluation and control of optical radiation hazards from all electrically powered sources of optical radiation that emit in the wavelength range from 200 nm through 3,000 nm (3.0 um [micrometers]) except for light emitting diodes (LEDs) used in optical fiber communication systems and for lasers which are covered in a separate series of ANSI (American National Standards Institute) standards (Series Z136). Federal mandatory requirements for lamps subject to specific Federal Regulations take precedence over requirements in subsequent standards included in this series.
Extent of Recognition
Complete standard
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*
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 Organizations
ANSI American National Standards Institute https://www.ansi.org/
IES Illuminating Engineering Society https://www.ies.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.