Medical Lasers

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class="col-md-8 col-md-push-2" role="main"> <p><a class="pull-right btn btn-info" href="/radiation-emitting-products/laser-products-and-instruments/notices-laser-industry">Notices to the Laser Industry</a></p> <ul> <li><a href="#d">Description</a></li> <li><a href="#p">Procedures</a></li> <li><a href="#rb">Risks/Benefits</a></li> <li><a href="#ipp">Information for Patients and Professionals </a></li> <li><a href="#lrps">Laws, Regulations & Performance Standards </a></li> <li><a href="#ig">Industry Guidance </a></li> <li><a href="#ig">Other Resources </a></li> </ul> <hr> <h2><a id="d" name="d"></a>Description</h2> <p>Medical lasers are medical devices that use precisely focused light sources to treat or remove tissues.</p> <p>The term “laser” stands for Light Amplification by Stimulated Emission of Radiation. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, on the other hand, has a specific wavelength. It is focused in a narrow beam and creates a very high-intensity light. Because lasers can focus very accurately on tiny areas, they can be used for very precise surgical work or for cutting through tissue (in place of a scalpel).</p> <h2><a id="p" name="p"></a>Procedures</h2> <p>Lasers are used in many types of surgical procedures. Some examples include</p> <ul> <li>Cosmetic surgery (to remove <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="d266ea4e-bf59-440a-8b7b-6acaf45e1b5c" href="/consumers/consumer-updates/tattoo-removal-options-and-results" title="Tattoo Removal: Options and Results">tattoos</a>, scars, stretch marks, sunspots, wrinkles, birthmarks, spider veins or hair)</li> <li>Refractive eye surgery (to reshape the cornea in order to correct or improve vision as in LASIK or PRK)</li> <li>Dental procedures (such as endodontic/periodontic procedures, tooth whitening, and oral surgery)</li> <li>General surgery (such as tumor removal, cataract removal, breast surgery, plastic surgery and most other surgical procedures)</li> </ul> <h2><a id="rb" name="rb"></a>Risks/Benefits</h2> <p>With proper use, lasers allow the surgeon to accomplish more complex tasks, reduce blood loss, decrease postoperative discomfort, reduce the chance of wound infection, and achieve better wound healing.</p> <p>As with any type of surgery, laser surgery has potential risks. Risks of laser surgery include incomplete treatment of the problem, pain, infection, bleeding, scarring, and skin color changes.</p> <p>Laser surgery uses non-ionizing radiation, so it does not have the same long-term risks as x-rays or other types of ionizing radiation.</p> <h2><a id="ipp" name="ipp"></a>Information for Patients and Professionals</h2> <ul> <li><a href="/radiation-emitting-products/laser-products-and-instruments/frequently-asked-questions-about-lasers">Frequently Asked Questions about Lasers</a></li> <li><a href="https://wayback.archive-it.org/7993/20180424190505/https://www.fda.gov/Radiation-EmittingProducts/ResourcesforYouRadiationEmittingProducts/ucm252757.htm" target>CDRH Consumer Information: Laser Facts</a></li> <li><a href="/lasik">LASIK Eye Surgery</a></li> <li><a href="/phakic-intraocular-lenses">Phakic Intraocular Lenses</a></li> </ul> <h2><a id="lrps" name="lrps"></a><strong>Laws, Regulations & Performance Standards </strong></h2> <p>Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the <a href="http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partC-sec360ii.htm">Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control</a>.</p> <p>Manufacturers of surgical laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:</p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1000">1000 - General</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1002">1002 - Records and Reports</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1003">1003 - Notification of defects or failure to comply</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1004">1004 - Repurchase, repairs, or replacement of electronic products</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1005">1005 - Importation of electronic products</a></p> <p>In addition, surgical lasers must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010, 1040.10, and 104.11:</p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1010">1010 - Performance standards for electronic products: general</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.10">1040.10 - Lasers and Products Incorporating Lasers</a></p> <p class="nudge-right"><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.11">1040.11 - Specific Purpose Laser Products</a></p> <p>Because they are medical devices, surgical laser products must also comply with the medical device regulations. For more information, see <a href="/how-study-and-market-your-device">Getting to Market with a Medical Device</a>.</p> <h2>Required Reports for the Medical Laser Manufacturers or Industry</h2> <ul> <li><a href="/media/72593/download">Guide for Preparing Product Reports on Lasers and Products Containing Lasers</a></li> <li><a href="/media/72606/download">Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show</a></li> </ul> <h2><a id="ig" name="ig"></a>Industry Guidance - Documents of Interest</h2> <ul> <li><a href="https://www.federalregister.gov/articles/2013/06/24/2013-14846/laser-products-proposed-amendment-to-performance-standard" target="_blank">Federal Register - Laser Products; Proposed Amendment to Performance Standard</a></li> <li><a href="/media/74026/download">Compliance Guide for Laser Products (FDA 86-8260) (PDF Only)</a></li> <li><a href="/radiation-emitting-products/laser-products-and-instruments/frequently-asked-questions-regarding-laser-notice-53-guidance-industry-and-fda-staff-approval">Frequently Asked Questions Regarding the Laser Notice 53 - Guidance for Industry and FDA Staff - Approval of Alternate Means of Labeling for Laser Products (issued March 23, 2007)</a></li> <li><a href="https://wayback.archive-it.org/7993/20190918100559/https://www.fda.gov/media/75838/download">Tabulated Values of Accessible Emission Limits for Laser Products</a></li> <li><a href="/radiation-emitting-products/laser-products-and-instruments/notices-laser-industry">Notices to the Laser Industry</a></li> <li><a href="/media/75913/download">Quality Control Practices for Compliance with the Federal Laser Product Performance Standard</a></li> <li><a href="/radiation-emitting-products/home-business-and-entertainment-products/date-manufacture-label-radiation-emitting-consumer-electronics">Date of Manufacture Label on Radiation-Emitting Consumer Electronics</a></li> <li><a href="/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/guidance-industry-and-fda-staff-addition-urls-electronic-product-labeling">Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="fbf6a7c4-4efc-4596-9c9f-0defa20e7531" href="/radiation-emitting-products/submitting-reports-and-requirements-maintaining-records-radiation/electronic-product-radiation-control-eprc-variance-application-process-fda" title="Electronic Product Radiation Control (EPRC) Variance Application Process| FDA">Variance Application Process</a></li> </ul> <h2>Other Resources</h2> <ul> <li><a href="/medical-devices/classify-your-medical-device/does-product-emit-radiation">Does the Product Emit Radiation?</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="cb90bf36-1630-4e55-a059-a46a9ed38ae2" href="/radiation-emitting-products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-questions" title="Getting a Radiation Emitting Product to Market: Frequently Asked Questions">Getting a Radiation Emitting Product to Market</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ea6941c7-154a-49b6-8a1a-9c494edf5bbb" href="/radiation-emitting-products/getting-radiation-emitting-product-market-frequently-asked-questions/submitting-reports-and-requirements-maintaining-records-radiation" title="Submitting Reports and Requirements for Maintaining Records for Radiation">Records and Reporting (Radiation-Emitting Products)</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="94abf438-6faf-40c4-990e-0e7294f22c77" href="/industry/fda-esubmitter" title="FDA eSubmitter">FDA eSubmitter</a></li> <li><a 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