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Recognized Consensus Standards

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Recognition List Number: 028 FR Publication Date: 03/16/2012 

Part B: Supplementary Information

Recognition Number 12-242: IEC 60601-2-57 Edition 1.0 2011-01, medical electrical equipment - part 2-57: particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use. (Radiology)

Date of Standard: 2011. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
CDRH Office and Division associated with recognized standards:
Devices Affected:
This will affect all non-laser light based products that are submitted for marketing having medical indications for use including therapeutic and diagnostic uses (Note: CDRH/ODE does not recognize "cosmetic/aesthetic" as a separate category).
Processes Affected:
These devices could be reviewed under 510(k); de Novo; or PMA depending on technology and indications for use. This could also affect non-laser light based devices that are used in photodynamic therapy that may be approved under an NDA or PMA.
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard except the following clauses/sub-clauses:

201.10.104 (a) Controls and indicators - Key-operated master control Emergency Stop
Related CFR Citations and Product Codes:
Device Name Device
Unclassified System, Laser, Photodynamic Therapy Class 3 MVF
§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
§878.5400 Fat Reducing Low Level Laser Class 2 OLI
§890.5500 Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Class 2 NHN
Relevant Guidance:
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use

Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices
FDA Technical Contact:
 Richard P. Felten
  10903 New Hampshire Avenue WO66 RMG466
  Silver Spring MD 20993
  email: richard.felten@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036