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).

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)

• Frequently Asked Questions about Lasers (January 26, 2006)
• CDRH Consumer Information: Laser Facts
• LASIK Eye Surgery
• Phakic Intraocular Lenses

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.

• Guide for Preparing Product Reports on Lasers and Products Containing Lasers (PDF) (PDF - 1.1MB)
• Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF) (PDF - 796KB)

• Federal Register - Laser Products; Proposed Amendment to Performance Standard
• Compliance Guide for Laser Products (FDA 86-8260) (PDF Only) (PDF - 105KB)
• 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)
• Tabulated Values of Accessible Emission Limits for Laser Products (PDF - 1.7MB)
• Notices to the Laser Industry
• Quality Control Practices for Compliance with the Federal Laser Product Performance Standard (PDF - 1.1MB)
• Date of Manufacture Label on Radiation-Emitting Consumer Electronics
• Tabulated Values of Accessible Emission Limits for Laser Products (PDF - 1.7MB)
• Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling