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The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, or frontal, both with Fitzpatrick Skin Types I to IV.

Similar to the Hair Laser Helmet, the Hair Laser Headband is a low-level laser device and is intended/indicated for over- the-counter use. The device emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp at 655 +/- 5 nanometers with an individual laser output of 5mW per laser diode. The lasers are configured inside a headband, designed for hands-free operation during treatment. The laser headband is for portable use with rechargeable battery.

Here's a breakdown of the acceptance criteria and study information for the Hair Laser Headband, based on the provided FDA 510(k) summary:

This device (Hair Laser Headband) is claiming substantial equivalence to a predicate device (Hair Laser Helmet, K160728). Therefore, the provided documentation focuses on demonstrating that the new device performs similarly to the predicate, rather than presenting a new clinical study with specific acceptance criteria related to efficacy beyond what was established for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Risk Management activities performed to ISO 14971:2012; all residual risks found acceptable.
• Bench testing indicates the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet. |
  | Maintain efficacy characteristics of predicate device (Hair Laser Helmet) | - Bench testing indicates the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet.
• Modifications (size/dimensions, reduced diodes) have no effect on efficacy, as users are instructed to move the device in three sections of the head to achieve the same surface treatment as the Hair Laser Helmet.
• "In all instances, the Hair Laser Headband performed as intended." |
  | Meet intended use and indications for use of predicate device | - Exact same indications for use as the Hair Laser Helmet. |
  | Share fundamental scientific/technological characteristics with predicate device | - Same wavelength (655 +/- 5 nm), individual laser output (5mW per diode), treatment regimen (20 min, 3x/week), materials, delivery method, helmet-like design, single on/off button, rechargeable battery. |

No specific numerical acceptance criteria (e.g., "improvement in hair count by X%") are provided in this submission for the Hair Laser Headband, as its clearance is based on substantial equivalence to a previously cleared device. The implicit acceptance criterion is that its performance (safety and efficacy) is equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a separate clinical "test set" in the traditional sense for the Hair Laser Headband's efficacy. Instead, it relies on:

• Bench Testing: To verify output parameters and dose rate characteristics. No sample size for this is specified, but it would typically involve a small number of manufactured units.
• Risk Analysis: Performed to ISO 14971:2012.
• Design Verification and Validation: Performed per 21 CFR 820.30.

The data provenance for these activities would be internal to Pulsaderm LLC, likely in the US, and prospective as part of the device's development and validation.

For the predicate device (Hair Laser Helmet, K160728), a clinical study would have been conducted to establish its efficacy, but details about that study (sample size, provenance, etc.) are not included in this 510(k) summary for the Hair Laser Headband.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission does not describe a clinical test set requiring expert ground truth for the Hair Laser Headband's efficacy. Its performance is compared to the predicate device through bench tests and design controls.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a laser treatment device for hair growth, not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the Hair Laser Headband itself, the "ground truth" for its performance is established through:

• Bench Test Results: Demonstrating equivalent output parameters and dose rate to the predicate.
• Compliance with Standards: (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971).
• Design Verification and Validation: Performed according to regulatory requirements.
• Risk Analysis: Ensuring safety.

The efficacy "ground truth" is implicitly linked to the predicate device's prior clearance, which would have been based on clinical data (likely hair counts, photographic assessment, patient self-assessment) from a study on the Hair Laser Helmet. Details of that ground truth are not provided here.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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