Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-168: IEC 60825-1 Ed. 2.0 (2007), Safety of laser products - Part 1: Equipment classification, and requirements. (Radiology)
Date of Standard: 2007. |
| 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) | | DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DMQRP) |
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| (2) | OFFICE OF DEVICE EVALUATION (ODE) | | |
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| (3) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
| Deals with the safety of laser products. Covers laser radiation in the wavelength range 180 nm to 1 mm, indicates safe working levels of laser radiation and introduces a system of classification of lasers and laser products according to their degree of hazard. Replaces IEC 60825 (1984) and IEC 60820 (1986). Has the status of a group safety publication in accordance with IEC Guide 104. |
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| Processes Affected: |
| 510(K), PMA, IDE, Initial reports |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Device, Angioplasty, Laser, Coronary |
Class 3 |
LPC |
| Unclassified |
Device. Laser Peripheral Angioplasty |
Class 3 |
LWX |
| Unclassified |
Excimer Laser System |
Class 3 |
LZS |
| Unclassified |
Laser For Gastro-Urology Use |
Class U |
LNK |
| Unclassified |
Laser, Dental |
Class U |
LYB |
| 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 |
| §874.4490 |
Laser, Microsurgical Argon, For Use In Otology |
Class 2 |
LXR |
| §874.4490 |
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolarngology |
Class 2 |
LMS |
| §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 |
| §884.4550 |
Laser, Neodymium:Yag For Gynecologic Use |
Class 2 |
LLW |
| §884.4550 |
Laser, Surgical, Gynecologic |
Class 2 |
HHR |
| §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 |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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