| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
036
|
Date of Entry 07/09/2014
|
|
FR Recognition Number
|
12-273
|
| Standard | |
IEC 60825-1 Edition 2.0 2007-03
Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] |
|
Scope/AbstractThis International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.
This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. |
|
| Extent of Recognition
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §874.4490 |
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
|
Class 2
|
LMS
|
| §874.4490 |
Laser, Microsurgical Argon, For Use In Otology
|
Class 2
|
LXR
|
| §874.4500 |
Laser, Ent Microsurgical Carbon-Dioxide
|
Class 2
|
EWG
|
| §874.4500 |
Laser, Neodymium:Yag, Pulmonary Surgery
|
Class 2
|
LLO
|
| §878.4810 |
Powered Laser Surgical Instrument
|
Class 2
|
GEX
|
| §878.4810 |
Laser For Gastro-Urology Use
|
Class 2
|
LNK
|
| §884.4550 |
Laser, Surgical, Gynecologic
|
Class 2
|
HHR
|
| §884.4550 |
Laser, Neodymium:Yag For Gynecologic Use
|
Class 2
|
LLW
|
| §886.4390 |
Laser, Ophthalmic
|
Class 2
|
HQF
|
| §886.4392 |
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
|
Class 2
|
LXS
|
| §886.4670 |
Laser, System, Phacolysis
|
Class 2
|
MXO
|
| §886.4690 |
Photocoagulator And Accessories
|
Class 2
|
HQB
|
| N/A |
Laser, Neurosurgical |
Class 3
|
LKW
|
| N/A |
Laser, Neurosurgical, Argon |
Class 3
|
LLF
|
| N/A |
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
Class 3
|
LOI
|
| N/A |
Device, Angioplasty, Laser, Coronary |
Class 3
|
LPC
|
| N/A |
Device. Laser Peripheral Angioplasty |
Class 3
|
LWX
|
| N/A |
Excimer Laser System |
Class 3
|
LZS
|
| N/A |
System, Laser, Transmyocardial Revascularization |
Class 3
|
MNO
|
| N/A |
System, Laser, Photodynamic Therapy |
Class 3
|
MVF
|
| N/A |
System, Laser, Fiber Optic, Photodynamic Therapy |
Class 3
|
MVG
|
|
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 Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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