(66 days)
The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.
Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).
The provided text is a 510(k) summary for the SMOOTHSHAPES® XV System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as requested in your prompt.
Specifically, the document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices (Elemé SmoothShapes (K083629) and Syneron Velashape (K071872)) for the indications of use. It does not provide:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
- Information on adjudication methods, MRMC studies, or standalone algorithm performance.
- Specifics about the type of ground truth used or the size and ground truth establishment for a training set.
The document mostly outlines the administrative and regulatory aspects of the device's clearance.
§ 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.