(92 days)
The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The family of DermaScalp Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength,
This document, a 510(k) Summary for the DermaScalp Laser Cap, describes performance data and criteria primarily in the context of demonstrating substantial equivalence to predicate devices, rather than a standalone evaluation against specific, quantitative acceptance criteria for its effectiveness in treating androgenetic alopecia and promoting hair growth.
The document focuses on comparing the DermaScalp Laser Cap's design, intended use, and general performance with existing FDA-cleared devices (predicates) to argue for substantial equivalence. It does not present a detailed study proving the device meets quantitative acceptance criteria for clinical efficacy through a direct clinical trial with a defined sample size and ground truth for efficacy.
However, it does describe a usability study with specific acceptance criteria.
Here's a breakdown of the information based on the provided document, addressing your specific questions to the best extent possible given the information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Usability Study) | Reported Device Performance (from Usability Study) |
|---|---|
| User comprehension of user instructions, warnings, and precautions resulting in a pass rate for self-selection | 93% pass rate (self-selection) |
| User comprehension of user instructions, warnings, and precautions resulting in a pass rate for user instruction questionnaire | 99.4% pass rate (user instruction questionnaire) |
| Compliance to design specifications for all functions | All functions verified to operate as designed. |
| Adherence to IEC 60601-1 and 60601-1-2 for LVD electrical and EMC safety requirements | Confirmed adherence. |
| Certification to Class 3R laser system according to IEC 60825-1 | Certified to classification 3R. |
| Compliance with IEC 60601-1-11:2015 for basic safety and essential performance in home use | Confirmed. |
| Same or similar Laser Wavelength as predicate devices | 650 nm (predicate devices range 635-678nm) |
| Same or similar Laser Power as predicate devices |
§ 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.