(84 days)
The Diode Laser System is intended for use in dermatologic and general surgical procedures. The Fast Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Free Mode is intended for hair removal of unwanted hair, and permanent hair regrowth. The Diode Laser System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The permanent reduction in hair regrowth is defined as long-term, stable reduction in the number of hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The Diode Laser System is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (810 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The proposed Diode Laser System has two models, GP900A8 and GP900Q8. Both GP900A8 and GP900Q8 have the same functions modules, such as the power supply system, central control system, cooling system, laser delivery system and safety feature, and same working mode, such as Fast mode and Free mode.
The GP900A8 is a standard case with wheels to allow easy movement on the floor. The GP90008 is a desktop case.
I am sorry, but the provided text does not contain information about acceptance criteria and device performance for an AI/ML device or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a Diode Laser System, which is a physical medical device, not an AI/ML software. It primarily focuses on demonstrating substantial equivalence to a predicate device through technical specifications, intended use, and non-clinical safety tests.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- If an MRMC comparative effectiveness study was done and its effect size.
- If a standalone (algorithm only) performance was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the 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.