Recognition List Number: 028 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 Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| 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). |
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| 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. |
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| 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
201.12.4.101 Emergency Stop |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
System, Laser, Photodynamic Therapy |
Class 3 |
MVF |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.5400 |
Fat Reducing Low Level Laser |
Class 2 |
OLI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.5500 |
Powered Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
Class 2 |
ONH |
| §890.5500 |
Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
Class 2 |
NHN |
| |
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| 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 |
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| FDA Technical Contact: |
| 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 |
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