(87 days)
Each device is indicated for emitting 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, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
The devices under submission are a family of laser that emits a beam of coherent light in either continuous wave or pulse mode at the wavelengths previously described. Each device is a table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.
The provided text describes a 510(k) premarket notification for a medical device (K-LASER, a family of infrared lamps) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the K-LASER devices are substantially equivalent to previously cleared predicate devices (K091497 and K061656) due to sharing the same intended use, similar design, and functional features, without raising new issues of safety or effectiveness.
- Performance Standards: The document states that the device conforms to applicable requirements of 21 CFR section 1010, 21 CFR sections 1040.10, and 1040.11 (Performance Standards for Light-Emitting Products). These are general regulatory standards, not specific performance criteria for a study.
- Safety and Effectiveness Rationale: The submission asserts safety and effectiveness based on the similarity to predicate devices, adherence to quality management systems (21 CFR Part 820), design/change control, and verification/validation to applicable standards/guidance documents.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets these criteria, because such information is not present in the provided text. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a detailed report of a clinical or performance study demonstrating 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.