Surgical Lasers Market - Restraints
Limitations such as surgeons’ specialized training, strict safety precautions, and high cost of laser therapy is expected to negatively impact surgical laser market growth over the forecast period. Moreover, in some cases such as cancer, the effects of laser therapy may not last longer, so doctors might have to repeat the treatment to get better results.
As surgical lasers are categorized into medical devices, these products must also comply with the medical device regulations. Medical devices marketed in the U.S. are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299. Medical devices that emit radiation are also subject to regulations for radiation-emitting electronic products cited in 21CFR Parts 1000-1050. Manufacturers developing surgical lasers are required to fulfil these stringent norms, in order to bring their product into the market.
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