(144 days)
Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing -Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood -Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
Not Found
This document is an FDA 510(k) clearance letter for a "Hair Growth System", not a study report or clinical trial summary. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance.
The provided text only includes:
- General FDA clearance information.
- The device name, regulation number, regulatory class, and product code.
- The indications for use for the Hair Growth System.
It emphatically does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
- Information about MRMC studies, standalone algorithm performance, or the type of ground truth used.
- Details about training set size or how its ground truth was established.
Without a clinical study report or a summary of the performance data submitted for the 510(k) clearance, these questions cannot be answered from the provided text.
§ 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.