Radiation-Emitting Products

Medical Lasers

Notices to the Laser Industry


Description 

Medical lasers are medical devices that use precisely focused light sources to treat or remove tissues.

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).

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Procedures

Lasers are used in many types of surgical procedures. Some examples include

  • Cosmetic surgery (to remove tattoos, scars, stretch marks, sunspots, wrinkles, birthmarks, spider veins or hair)
  • Refractive eye surgery (to reshape the cornea in order to correct or improve vision as in LASIK or PRK)
  • Dental procedures (such as endodontic/periodontic procedures, tooth whitening, and oral surgery)
  • General surgery (such as tumor removal, cataract removal, breast surgery, plastic surgery and most other surgical procedures)

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Risks/Benefits

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.

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.

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.

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Information for Patients and Professionals

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Laws, Regulations & Performance Standards 

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 compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

1000 - General

1002 - Records and Reports

1003 - Notification of defects or failure to comply

1004 - Repurchase, repairs, or replacement of electronic products

1005 - Importation of electronic products

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:

1010 - Performance standards for electronic products: general

1040.10 - Lasers and Products Incorporating Lasers

1040.11 - Specific Purpose Laser Products

Because they are medical devices, surgical laser products must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.

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Page Last Updated: 09/18/2014
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