5c890697-9cb2-4f07-9356-b3b218fd9fd2NewPublished12020-12-102020-12-02In Commercial DistributionB399PRO0800PrimaryHIBCCPRO LH80PRO LH80PRO LH80062441213Theradome, Inc.1Theradome PRO LH80 laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimultion of the scalp.falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsetrueLabeling does not contain MRI Safety Informationfalsetrue1-855-549-6757support@theradome.comK12295000047417Hair growth laser deviceAn electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.falseActiveOAPLaser, Comb, HairStorage Environment TemperatureStorage Environment HumidityStorage Environment Atmospheric Pressurefalsefalse