(7 days)
The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XLi] includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The Alma Lasers Soprano XLi system is a multi-application, multi-technology platform that supports the following technologies:
- · Diode laser technology
- · Near-infrared light technology (NIR) .
The complete Soprano XLi platform consists of its console, two available module handpieces and a footswitch (refer to Figure 1). The module is pressed against the patient's skin and a light pulse is delivered when the handpiece trigger and/or the footswitch are activated. The handpiece tip is cooled to provide active and continuous skin cooling.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
The provided text describes a 510(k) summary for a modified Alma Lasers family of Soprano™ Diode Laser Systems, but it does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices. It states:
- The modified device "has the same intended use and indications for use."
- "Uses the same operating principle (technology)."
- "Incorporates the same basic design."
- "Incorporates the same materials."
- "Is packaged using the same materials and processes."
Therefore, rather than presenting new performance data against specific acceptance criteria, the submission relies on the established safety and effectiveness of the predicate devices.
Based on the provided text, I cannot answer the requested questions as the information is not present. The summary explicitly concludes that the device "was found to be substantially equivalent to the predicate Soprano Family systems and devices." This implies that new, separate performance studies to establish new acceptance criteria were not conducted or reported in this 510(k) summary because the device is considered equivalent to already approved devices.
§ 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.