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The BIOFLEX LD-R100 Treatment head device is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The BIOFLEX LD-R100 Treatment head device is to be used with the Low Intensity Laser Therapy System, BioFlex Professional System & the Prescription Unit and Related Treatment Heads. These systems were cleared under 510(k) submission K023621 & K051875 respectively. The treatment head device is a Class II Low Level Laser treatment head that apply energy, which penetrates the surface to the underlying tissues, and triggers normal cellular functions.

The LD-I-75 and LD-I-200 "" treatment heads are indicated for adjunctive use in the temporary relief of pain associated with rotator cuff tendonitis.

The BioFlex™ System and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, and low cost benefit to the patient, the practitioner and the health care system.

The BioFlex™ Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The BioFlex™ Prescription Unit and related Treatment Heads are designed for clinical applications to provide low level light therapy and and display system parameters as part of the treatment session. This device does NOT store patient data. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY. The BioFlex™ Prescription Unit and related Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system. The BioFlex™ Prescription Unit and related Treatment Heads is a" multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.

The BioFlex™ LD-175& LD-1200 Treatment Heads are intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

The BioFlex™ LD-175 & LD-1200 Treatment Heads are designed to be used only part of the BioFlex Professional System. This system was cleared in K023621. This system provides a low level Dior tex I royessional bysied displays the treatment sessions. As such, this device is a Class II device, having Regulation Number: 21 CFR part 890.5500. Product Code ILY. The BioFlex™ LD-175 & LD-1200 Treatment Heads are described as a Class II Low Level Laser treatment heads that apply energy, which penetrates the skin surface to the underlying tissues, and triggers normal cellular functions that lead to a surgery-free, drug-free, and low cost benefit to the patient, the practitioner and the health care system. This device is different from other predicate devices in that it is part of a regiment that uses proprietary, interchangeable treatment heads to allow various protocols (and software loaded in a P.C. computer to download protocols) and record session / patient data.

The BioFlex "" Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The "Indications for Use" for this device cover three therapeutic applications; - relief of neck and shoulder pain, and . - relief of muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting . relaxation of muscle tissue.

The BloFlex ™ Professional Therapy System is designed for clinical applications to provide low level light therapy and record and display treatment sessions. This device is composed of: - software {that runs in a qualified, ancillary computer}, ● - proprietary hardware and software, and . - flexible treatment heads. ● The BioFlex ™ Professional Therapy System is a "multi-mode" low level light treatment system configured for multiple treatment heads powered by a flexible protocol controller that delivers various treatment protocols.