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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

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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.

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