(147 days)
The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.
The DermaScalp MD Laser Cap and the DermaScalp MDX 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 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 describes the DermaScalp Laser Cap, a device for promoting hair growth in females with Androgenetic Alopecia. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with detailed acceptance criteria and a clinical trial.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical efficacy endpoints (e.g., hair count increase, patient satisfaction). Instead, it relies on demonstrating that the new device has "the same or similar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode, Treatment Time, Output Beam, Laser Field Treatment Area, Consumer Usage Focal Length as the FDA Cleared predicate devices."
The performance data listed confirms adherence to safety standards and comparison to predicate device specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy (Not explicitly stated) | Similar to predicate devices' demonstrated efficacy in promoting hair growth in specified female population. | Not directly assessed with new clinical trials; deemed equivalent to predicate based on technological similarity. |
| Laser Wavelength | 650nm (as per predicate) | 650nm |
| Laser Power (each diode) |
§ 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.