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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 033 Date of Entry 01/14/2014 
FR Recognition Number 12-268
Standard(Included in ASCA pilot)
IEC 60601-2-22 Edition 3.1 2012-10
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT.

Throughout this International Standard, light emitting diodes (LED) are included whenever the word "laser" is used.
Extent of Recognition
Complete standard
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
Unclassified Device, Angioplasty, Laser, Coronary Class 3 LPC
Unclassified Excimer Laser System Class 3 LZS
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Unclassified Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary Class 3 LOI
Unclassified Laser, Neurosurgical Class 3 LKW
Unclassified Laser, Neurosurgical, Argon Class 3 LLF
Unclassified System, Laser, Fiber Optic, Photodynamic Therapy Class 3 MVG
Unclassified System, Laser, Photodynamic Therapy Class 3 MVF
Unclassified System, Laser, Transmyocardial Revascularization Class 3 MNO
§878.4810 Laser For Gastro-Urology Use Class 2 LNK
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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
 Richard P. Felten
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.