(213 days)
The Irradiation Cosmetic Device (Model: HairPro Plus) is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV
Irradiation Cosmetic Device (Model: HairPro Plus) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after each 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.
The provided FDA 510(k) summary for the "Irradiation Cosmetic Device (Model: HairPro Plus)" describes a device clearance based on substantial equivalence to predicate devices, rather than a study demonstrating clinical performance against established acceptance criteria for a new clinical claim.
Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies supporting novel clinical claims for AI/ML-driven devices, is largely not applicable to this submission. This device is cleared based on demonstrating that it is as safe and effective as existing legally marketed predicate devices, primarily through engineering and biocompatibility testing.
Here's an breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The submission does not present a table of specific clinical acceptance criteria with corresponding performance metrics for hair growth promotion. Instead, the "acceptance criteria" are implied by compliance with various safety and performance standards for medical electrical equipment and biocompatibility, as well as demonstrating substantial equivalence to predicate devices in their design, intended use, and specifications.
The table in the document (pages 5-6) is a comparison table to predicate devices, not a performance table against clinical acceptance criteria for the subject device itself. It indicates that the subject device's specifications (e.g., wavelength, energy, treatment time, irradiance, fluence) are comparable to those of the predicate devices. The "Verdict" column indicates "SE" (Substantial Equivalence) rather than a specific performance measure.
| Elements of Comparison | Subject Device (Irradiation Cosmetic Device, Model: HairPro Plus) Performance/Specification | Predicate Device 1 (HairPro) Performance/Specification | Predicate Device 2 (Capillus272 Pro, etc.) Performance/Specification | Acceptance Criteria (Implied by Substantial Equivalence and Standards) |
|---|---|---|---|---|
| Intended Use / Indications for Use | Promote hair growth in females (Ludwig-Savin Class I-II) and males (Norwood-Hamilton Class IIa-V) with androgenetic alopecia, Fitzpatrick Skin Phototypes I-IV. | Same | Same | Substantially equivalent to predicate devices. |
| Wavelength | 650nm ±5nm | 650nm ±5nm | 650nm | Within range of predicate devices. |
| Energy per Laser Lamp | 5mW ±10% | 5mW ±10% |
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.