(227 days)
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.
This document is a 510(k) summary for the BioFlex™ LD-175 & LD-1200 Treatment Heads and does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on:
- Device Description and Intended Use: The BioFlex™ LD-175 & LD-1200 Treatment Heads are Class II Low Level Laser treatment heads that apply energy in the infrared spectrum for topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of muscle tissue. It is a prescription-only device.
- Substantial Equivalence: The manufacturer, Meditech International Inc., asserts that these treatment heads are substantially equivalent to three predicate devices: K 033768 (Altus Medical, Inc.), K031612 (Avicenna Laser Technology, Inc.), and K024179 (Palomar Medical Products).
- Quality System and Calibration: It states that the device "has benefited from design, development, testing and production procedures that conform to Quality Systems" and that "A series of factory calibration tests are conducted to verify the device is accurate and calibrated (and can maintain calibration over its useful life)."
- Safety and Effectiveness: A general statement is made that the device "is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy."
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study (sample size, data provenance, ground truth establishment, etc.) that demonstrates the device meets pre-defined acceptance criteria for safety or effectiveness.
- Information on expert involvement, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the provided text. The document acts as a submission for regulatory clearance based on substantial equivalence to existing devices, rather than a detailed report of a performance study against specific acceptance criteria.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.