• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 12-179: ANSI / IESNA RP-27.3-2007, recommended practice for photobiological safety for lamps - risk group classification and labeling. (Radiology)

Date of Standard: 2007. 
Addresses of Standards Development Organizations:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 Illuminating Engineering Society of North America (IESNA)
  120 Wall Street
  New York, NY 10005-`
 
CDRH Offices and Divisions associated with recognized standards:
(1)OFFICE OF DEVICE EVALUATION (ODE)
(2)OFFICE OF COMPLIANCE (OC)
(3)OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)
(4)OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)
Devices Affected:
All devices and products that emit non-coherent (i.e., non-laser) optical radiation
Processes Affected:
510(k), IDE, PMA, PDP, HDE, Design Control Input
Type of Standard:
 Horizontal, National
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
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
Relevant Guidance:
21 CFR 860 Medical Device Classification Procedures, 2011

FD&C Act Chapter V Drugs and Devices, Subchapter C Electronic Product Radiation Control (21 U.S.C. 360hh - 360ss), 2006

21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology, 2011
FDA Technical Contacts:
 Sharon A. Miller
  FDA/CDRH/OCER
  10903 New Hampshire Avenue Building 66, Room 4661
  Silver Spring MD 20993
  301/796-2471
  email: sharona.miller@fda.hhs.gov
 Richard P. Felten
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1436
  Silver Spring MD 20993
  301/796-6392
  email: richard.felten@fda.hhs.gov
-
-