(39 days)
The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV
Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp.
The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.
Here's an analysis of the provided text regarding the illumiflow 148 Laser Cap, addressing your questions about acceptance criteria and study proving device performance:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel efficacy or new safety profiles. Therefore, some of the information you requested, particularly those related to detailed clinical study design (like MRMC studies, specific sample sizes for test/training sets in a clinical trial context, and ground truth establishment for clinical data), is either not present or is addressed in the context of equivalence to previously cleared devices.
Acceptance Criteria and Device Performance (Context of 510(k) - Substantial Equivalence)
For a 510(k) submission like this, "acceptance criteria" are not typically framed as specific performance metrics in a clinical study to prove de novo efficacy, but rather as demonstrations that the device is as safe and effective as a predicate device. The performance is assessed against the predicate's known safety and efficacy profile through non-clinical testing and comparison of technological characteristics.
Here's the closest interpretation of your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria (Based on Substantial Equivalence to Predicate) | Reported Device Performance (illumiflow 148 Laser Cap) |
|---|---|
| Safety and Electrical Compatibility | Conforms to IEC 60601-1 and 60601-1-2. |
| Laser Classification | Certified to Classification 3R (per IEC 60825-1). |
| Charger Conformance | Conforms to IEC-60950. |
| Home Use Safety | Conforms to IEC 60601-1-11. |
| Battery Pack Conformance | Conforms to IEC 62133. |
| Individual Diode Output Power |
§ 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.