Part 2: Low-Level Laser Therapy Devices, Medical Device Regulation, and Impact on Development

January 2015 in “ Hair transplant forum international ”

Sharon A. Keene

Low-Level Laser Therapy LLLT hair loss treatment Premarket Approval 510(k) Clearance medical devices laser therapy hair loss

TLDR Strict regulations may slow down new LLLT treatments.

The document discussed the classification and regulation of Low-Level Laser Therapy (LLLT) devices, particularly in the context of hair loss treatment. It highlighted the differences between "Premarket Approval" and "510(k) Clearance" processes for medical devices, emphasizing how these regulatory pathways impact the development and research of LLLT devices. The article concluded that stringent regulations could potentially slow down innovation and the availability of new treatments in the market.

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