Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-249: IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems. (Radiology)
Date of Standard: 2006. |
| 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 Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER) |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) |
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| (3) | OFFICE OF COMPLIANCE (OC) |
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| (4) | OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) |
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| Devices Affected: |
| All devices and products that emit non-coherent (i.e., non-laser) optical radiation |
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| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, Design Control Input |
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| Type of Standard: |
| Horizontal, International |
| Extent of Recognition: |
Complete standard with the following notes:
*Clause 6 Lamp Classification: Risk group classification defined in this clause do not correspond to the FDA's Medical Device Classification per 21 CFR 860 Medical Device Classification Procedures. They also have no bearing on any reporting requirements under the Electronic Product Radiation Control Provisions, Section 531 through 542 of the Federal Food, Drug, and Cosmetic Act.
*Subclause 4.1 Exposure limits - General: Spectral measurements for FDA-regulated products should be performed regardless of level of luminance of the source. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §878.4810 |
Laser Assisted Lipolysis |
Class 2 |
ORK |
| §878.4810 |
Laser, Benign Prostatic Hyperplasia |
Class 2 |
OEL |
| §878.4810 |
Laser, Cellulite Appearance |
Class 2 |
OYW |
| §878.4810 |
Laser, Dental, Soft Tissue |
Class 2 |
NVK |
| §878.4810 |
Light Based Over The Counter Wrinkle Reduction |
Class 2 |
OHS |
| §878.4810 |
Light Based Over-The-Counter Hair Removal |
Class 2 |
OHT |
| §878.4810 |
Massager, Vacuum, Light Induced Heating |
Class 2 |
NUV |
| §878.4810 |
Neurosurgical Laser With Mr Thermography |
Class 2 |
ONO |
| §878.4810 |
Over-The-Counter Powered Light Based Laser For Acne |
Class 2 |
OLP |
| §878.4810 |
Powered Laser Surgical Instrument |
Class 2 |
GEX |
| §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 |
| |
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| Relevant Guidance: |
21 CFR 860 Medical Device Classification Procedures, 2011
FD&C Act Chapter V Drugs and Devices, Subchapter C Electronic Product Radiation Control (21 U.S.C. 360hh - 360ss), 2006
21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology, 2011. |
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| FDA Technical Contacts: |
| Sharon A. Miller |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room 4661 |
| Silver Spring MD 20993 |
| 301/796-2471 |
| Email: sharona.miller@fda.hhs.gov |
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| 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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