Recognized Consensus Standards

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	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
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 Contacts

Sharon A. Miller

FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/

301-796-2471

sharona.miller@fda.hhs.gov

Richard P. Felten

FDA/OMPT/CDRH/ODE/DSD/GSDB1/

301-796-6392

richard.felten@fda.hhs.gov

Standards Development Organizations