Compliance Consultants worked on the first cosmetic laser system approved by the FDA to remove hair. Compliance Consultants has created many 510(k) applications for medical laser technology . The exponential growth of medical laser technology and the disparity in labeling, particularly for Indications for Use, led FDA to develop a guidance document in 1990. Comments were solicited on the format and content from laser manufacturers and the American Society for Laser in Medicine and Surgery, and other professional organizations.


Performance standards: All medical lasers must meet the performance standard for light emitting products (21 CFR 1040.10 & 1040.11).


Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm080653.htm


874.4490 Argon laser for otology, rhinology, and laryngology
874.4500 Ear, nose, and throat microsurgical carbon dioxide laser
878.4810 Laser for use in general and plastic surgery and in dermatology
884.4550 Gynecological surgical laser
886.4390 Ophthalmic laser
886.4392 Nd:YAG laser for posterior capsulotomy