(149 days)
The device FlexSys is a multi-modality skin surface treatment . Depending on the chosen modules the intended use and the mode of operation varies.
Module MultiLite:
The intended use of the device FlexSys with MultiLite module is:
· Blue 420 nm light: The GME FlexSys with Blue 420 MultiLite is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
· Yellow 585 nm light: The GME FlexSys with module Yellow 585 is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
· Red 635 nm Light: The GME FlexSys with Red 635 MultiLite is indicated in general to treat dermatological conditions and specifically indicated to treat superficial, benign vascular, and pigmented lesions.
Module Green 532:
The GME FlexSys with module Green 532 (wavelength: 532nm) is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
Module Yellow 577:
The GME FlexSys with module Yellow 577 (wavelength: 577mm) is intended for treatment of benign vascular and benign pigmented lesions.
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition the power cord, foot switch, and the door plug are connected to the base unit. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
The provided text is a 510(k) summary for the GME FlexSys device. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it explicitly states:
"Clinical Performance Data: None"
This means that no clinical study was conducted to prove the device's performance against specific acceptance criteria. The acceptance criteria and the study proving the device meets them are therefore not available in this document.
The document primarily focuses on demonstrating substantial equivalence based on:
- Technological similarity: Comparing the FlexSys's technology (laser and LED light sources) to predicate devices.
- Physical output characteristics: Assessing that the physical output of the FlexSys is similar to predicates.
- Indications for Use: Comparing the intended uses of the FlexSys modules to those of predicate devices.
- Design, materials, and performance: General comparisons to predicate devices without specific quantitative clinical data.
- Nonclinical tests: Conformance with standards for safety (electrical, EMC, laser safety), software validation, and biocompatibility.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document.
§ 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.