(128 days)
The REMY device emits energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm: the temporary increase in local blood circulation; and the temporary relaxation of muscle.
The REMY is intended for use in Podiation, vaporization, incision, and coagulation of soft tissue) including periungual, subungual, and plantar warts.
The REMY is also indicated for use for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc., and for the temporary increase of clear nail in patients with onychomycosis including dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc..
Not Found
The provided text is an FDA 510(k) clearance letter for the REMY Medical Therapy Laser System. This document is a regulatory communication and does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The letter confirms that the REMY Medical Therapy Laser System has been found substantially equivalent to pre-amendment devices or previously cleared predicate devices for its stated indications for use. This regulatory review primarily focuses on safety and effectiveness claims based on equivalence to existing devices, rather than requiring new clinical performance studies with specific acceptance criteria as might be seen for novel devices.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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.