Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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12-321
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Standard | |
ANSI IES RP-27.3-17 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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 |
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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. |
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FDA Technical Contacts
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Standards Development Organizations
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |