(29 days)
The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.
The Hair Boom Air diode laser is configured within an outer 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter and summary for a device called "Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom".
The document primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K223862), also named "Hair Boom Air, Hair Boom 69, Ulike Hair UpUp". The changes to the device are described as minor (controller design change, new timer mode, and color changes for helmet and controller).
Therefore, I cannot provide the requested information. The document explicitly states:
- "No clinical studies were considered necessary and performed."
- The determination of substantial equivalence relies on the device being "substantially equivalent to this device in design, function, and technical characteristics" to the predicate.
This means there is no new study described in this document that would establish acceptance criteria or demonstrate performance against such criteria for the current submission. The provided text is a regulatory clearance document, not a clinical study report.
§ 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.