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B.Light Clear Evo: - The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face. B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.

The BEMER devices are noninvasive, fully reusable components such as electrodes), and have configurations allowing both patient / home and professional / office use. The subject device is specific to the LED based applications. Low Level Light Therapy (LLLT) delivered via Light Emitting Diodes (LED) is a nonthermal technology used to modulate cellular activity with specific (nm) of light. Through photo biomodulation, photons are absorbed by chromophores within cells that are being treated. Various beneficial effects of LLLT delivered via light-emitting diodes at relatively low intensities have been reported, especially in indications where stimulation of healing, reduction of pain and inflammation, restoration of function, and skin rejuvenation are required. Light-emitting diode therapy (LED) is safe, nontoxic, and a noninvasive therapy for the treatment of Acne and the reduction of wrinkles and fine lines on the face.

- To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance

BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The indications for use allow application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance. The BEMER devices are noninvasive, fully reusable (no disposable components such as electrodes), and have configurations allowing both patient/home and professional/office use. This submission is specifically requesting to add the applicators, B.BODY and B.SIT to the already cleared BEMER Therapy System. The device contains firmware that controls the user interface. It also contains that controls the pulse generator, battery charger, audion and pushbutton controller.

BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for: - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance

BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission. BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.