| 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 |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 12-242 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
| FDA Tech | Richard P. Felten FDA/OMPT/CDRH/ODE/DSD/GSDB1/ 301-796-6392 richard.felten@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).
This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.
| Regulation Number | Device Name | Device Class | Product Code |
| §890.5500 | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | Class 2 | NHN |
| §878.5400 | Fat Reducing Low Level Laser | Class 2 | OLI |
| §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 |
| Unclassified | System, Laser, Photodynamic Therapy | Class 3 | MVF |
| 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 |