Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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043
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Date of Entry 06/27/2016
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FR Recognition Number
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12-297
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Standard | |
ANSI IES RP-27.1-2015 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
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Scope/AbstractThe 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.
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§878.4810 |
Powered Laser Surgical Instrument
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Class 2
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GEX
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§878.4810 |
Massager, Vacuum, Light Induced Heating
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Class 2
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NUV
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§878.4810 |
Laser, Dental, Soft Tissue
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Class 2
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NVK
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§878.4810 |
Laser, Benign Prostatic Hyperplasia
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Class 2
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OEL
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§878.4810 |
Light Based Over The Counter Wrinkle Reduction
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Class 2
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OHS
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§878.4810 |
Light Based Over-The-Counter Hair Removal
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Class 2
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OHT
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§878.4810 |
Over-The-Counter Powered Light Based Laser For Acne
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Class 2
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OLP
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§878.4810 |
Powered Light Based Non-Laser Surgical Instrument
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Class 2
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ONE
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§878.4810 |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
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Class 2
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ONF
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§878.4810 |
Powered Laser Surgical Instrument With Microbeam\Fractional Output
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Class 2
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ONG
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§878.4810 |
Neurosurgical Laser With Mr Thermography
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Class 2
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ONO
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§878.4810 |
Laser Assisted Lipolysis
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Class 2
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ORK
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§878.4810 |
Laser, Cellulite Appearance
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Class 2
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OYW
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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 Contact
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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. |