(90 days)
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.
The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip.
The provided text is a 510(k) summary for the LaserCap Family of Lasers, models 300, 224, 120, and 80, seeking Over-The-Counter (OTC) clearance for devices previously cleared for prescription-use. The core argument for substantial equivalence relies on the fact that the proposed OTC devices are identical to the previously cleared prescription-use predicate devices in their design, function, and performance. Therefore, no new clinical performance data or testing was performed for this submission.
This means that the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, because such studies were deemed unnecessary due to the device's substantial equivalence to already cleared devices.
The document explicitly states:
- "No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates..." (Page 4)
- "No OTC testing was performed for this submission because the User Manual and packaging contents for the predicates and reference devices, are substantially equivalent to the Reference Devices." (Page 5)
- "Biocompatibility, electrical safety and EMC testing is not needed in this submission because the subject device is identical to the predicate devices in these aspects." (Page 6)
In summary, the provided text does not include the details of a study that proves the device meets acceptance criteria in the way typically expected for a new or novel device. Instead, it relies on the established safety and efficacy of its identical predicate devices. Therefore, I cannot construct the requested table or answer most of the questions, as the information is not present in the provided context.
§ 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.