| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
|
FR Recognition Number
|
12-102
|
| Standard | |
ANSI IES RP-27.2-00/R17
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques |
|
Scope/AbstractThe ANSI/IES RP-27 series of standards applies to all electrically powered sources of optical radiation that emit in the wavelength range from 200 nm to 3,000 nm. The standards do not apply to any lasers or to those light emitting diodes used in optical fiber communication systems.
This standard is to be used by the radiometrist for guidance regarding special problems related to photobiological hazard measurements. Additionally, specific recommendations are included to provide consistency and to reduce test design time and effort.
It is impractical for this standard to teach all of the concepts or provide all experience needed to make accurate photobiological safety measurements. |
|
| Extent of Recognition
|
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 |
| §878.4635 |
Suntan Bed
|
Class 2
|
REF
|
| §878.4635 |
Suntan Lamp
|
Class 2
|
REG
|
| §878.4635 |
Tabletop Sunlamp System
|
Class 2
|
REH
|
| §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
|
| Standards Development Organizations
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
