(308 days)
The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
The diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is described in the table below:
The provided text describes a 510(k) premarket notification for a "Diode Laser for Hair Removal" (K131838) and references a predicate device (K112031). However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any details related to AI performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to the predicate device based on technical specifications and intended use. The table provided in the input is a comparison of the Honkon device's technical specifications to those of the predicate device (Alma Lasers 810nm Diode Laser System with HR Mode).
Therefore, I cannot fulfill the request for information on acceptance criteria, a proving study, sample sizes, expert details, or ground truth, as none of this information is present in the provided text.
Here's an output reflecting what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, it compares the technical specifications and intended use of the proposed device to a predicate device to establish substantial equivalence. The "performance" is implied by meeting similar specifications.
| Parameter | Predicate Device (K112031) Alma Lasers | Proposed Device (K131838) Honkon Diode Laser |
|---|---|---|
| Intended Use | Hair removal, permanent hair reduction (Fitzpatrick skin types I-VI), including tanned skin. | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. |
| Wavelength (nm) | 810 nm | 808 nm |
| Output power (W) | 30 W | 30 W |
| Fluence (Energy Density) |
§ 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.