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Medical Lasers | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/radiation-emitting-products/surgical-and-therapeutic-products/medical-lasers
- Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control. Manufacturers of surgical laser products are responsible for … See more
Compliance Guide for Laser Products (FDA 86-8260) | FDA
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-guide-laser-products-fda-86-8260
- It explains the performance, labeling, and informational requirements of the standard and the procedures for remedial actions and for variances or exemptions. It does not replace the …
Frequently Asked Questions About Lasers | FDA
- https://www.fda.gov/radiation-emitting-products/laser-products-and-instruments/frequently-asked-questions-about-lasers
- The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with …
Laser Products and Instruments | FDA
- https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments
- In addition, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) …
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