(183 days)
810 nm and 980nm wavelength:
LiteCure Therapy System, Model L TS-1500 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.
980nm wavelength:
LiteCure Therapy System, Model L TS-1500 is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.).
Not Found
The provided text focuses on the FDA's 510(k) clearance for the LiteCure Therapy System, Model LTS-1500. This is a regulatory document and does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.
Specifically, the document performs the following functions:
- Confirms 510(k) clearance: States that the device is substantially equivalent to a legally marketed predicate device.
- Lists device names and regulatory information: Provides the Trade/Device Name, Regulation Number, Regulation Name, and Regulatory Class.
- Defines Indications for Use: Specifies the medical conditions and purposes for which the device is intended (e.g., pain relief, increased local blood circulation, temporary increase of clear nail in onychomycosis).
- Provides regulatory guidance: Reminds the manufacturer of ongoing responsibilities under the Act.
The document does NOT contain any information about:
- Acceptance criteria: No specific metrics (e.g., sensitivity, specificity, accuracy, or a defined therapeutic outcome threshold) are mentioned.
- Device performance metrics: No reported performance data (e.g., how much pain relief was achieved, or the percentage increase in clear nail).
- Details of a study: No information on study design, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, based solely on the provided text, I cannot complete the table or answer the specific questions about the study that proves the device meets acceptance criteria. The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, and while it requires evidence of safety and effectiveness, the detailed study results and acceptance criteria are typically found in the 510(k) submission itself (which is not provided here), rather than in the final clearance letter.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.