(125 days)
Intended Use: The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.
Indications for Use: The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite. Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite.
The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems. The Accent UniForm Massager handpiece/module is comprised of the following main components: Handpiece Tip with Massage Ring, Handpiece Body (Handle used for holding the handpiece, A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission, A Thermo-electric cooler - integrated within the handpiece, provides contact cooling, A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece, A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.)
The provided text is a 510(k) summary for the Alma Lasers Accent UniForm Massager Handpiece/Module. It establishes substantial equivalence to predicate devices and describes the intended use and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document states:
"The review of the indications for use and technical characteristics provided demonstrates that the Accent UniForm Massager handpiece/module is substantially equivalent to the predicate devices."
And:
"The Accent UniForm Massager handpiece/module was found to be substantially equivalent to the predicate devices."
This indicates that the submission relies on demonstrating similarity to already approved devices rather than presenting a de novo study with specific performance metrics and acceptance criteria. Therefore, I cannot extract the requested information from the provided text.
§ 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.