(84 days)
The NOOANCE LED AND LASER HELMET is indicated to promote hair growth in males with androgenetic alopecia who have HamiltonNorwood Classifications of Ila-V and Fitzpatrick Classification of Skin Phototypes I to IV, and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
The NOOANCE LED AND LASER HELMET is an over-the-counter device designed to promote hair growth in person with androgenetic alopecia in women and men. The device is a combination of 650±5nm low-level laser diodes and 650±5nm light emitting diodes. Red light of specific spectrum combined with low-lever laser directly irradiated into hair follicles has been shown to help promote hair growth. It has two models, M-120 and M-282 PRO. The difference between them is the number of laser diodes (LDs) and light-emitting diodes (LEDs). The model M-120 is a combination of 51 class 1C low-level LDs and 69 LEDs. And the model M-282 PRO has 82 class 1C low-level LDs and 200 LEDs.
The device has two working modes. Mode 1 is continuous which has no frequency setting. Mode 2 is pulse with a frequency. User long presses the ON/OFF button to turn on the device and tap the ON/OFF button to select the preferred mode. Then press the start/pause button to start the treatment, treatment time is fixed for 25 minutes. The device is designed to automatically pause therapy if it is removed from the head and resume therapy when positioned on the head within 5 minutes and the start/pause button is pressed. Once the treatment complete, the device will turn off automatically with two "beep" sounds.
Here's an analysis of the provided text regarding acceptance criteria and study proving device performance:
Crucial Observation: The provided document is an FDA 510(k) clearance letter and its accompanying summary. It explicitly states in section 8.2: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."
Therefore, a study demonstrating the device meets performance criteria for hair growth promotion (which would typically involve clinical data) has not been provided or deemed necessary for this 510(k) clearance. The acceptance criteria and "study" described below refer primarily to the non-clinical performance and safety testing.
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
1. Table of Acceptance Criteria and Reported Device Performance
| Test Title | Acceptance Criteria | Reported Performance |
|---|---|---|
| General requirements for basic safety and essential performance (IEC 60601-1) | Test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (IEC 60601-1-2) | No degradation of performance was found during the test or lower than limits of measurement. | Pass |
| Requirements for medical electrical equipment & systems in home healthcare (IEC 60601-1-11) | Device operates normally, and can provide basic safety and essential performance. | Pass |
| Particular Requirements for Basic Safety & Essential Performance of Non-Laser Light Source Equipment (IEC 60601-2-57) | Test result is within the test acceptance range of the standard. | Pass |
| Photobiological safety of lamps and lamp systems (IEC 62471) | Test result is within the test acceptance range of the standard. | Pass |
| Safety of laser products - Part 1: Equipment classification & requirements (IEC 60825-1) | Test result is within the test acceptance range of the standard. | Pass |
| Biocompatibility | Component materials for outer shell and controller are identical to predicate device materials cleared in K230336 in formulation, processing, sterilization, and geometry, with no other chemicals added. | Compliant (Similar to K230336) |
| Usability Testing (IEC 62366-1, IEC 60601-1-6) | Device complies with the standards. | Complies |
| Software Verification & Validation | Documentation provided as recommended by FDA guidance. Considered "moderate" level concern, as malfunction would likely lead to Minor Injury. | Conducted, Documentation Provided |
| Cybersecurity | No external interfaces, adhering to FDA guidance. | Compliant (No external interfaces) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For all non-clinical performance tests (electrical safety, EMC, photobiological safety, laser safety), the "test sample is the final, finished product." This generally implies that a representative number of units (typically 1-3, but not explicitly stated as a statistical sample for a clinical trial) were subjected to these engineering and safety tests.
- Data Provenance: The tests are described as lab bench testing performed on the final product. The document does not specify the country of origin where these lab tests were conducted. The application is from Shenzhen, China, so it's likely the tests were conducted there or by a certified lab associated with the manufacturer. The data is retrospective in the sense that results are reported after the testing has been completed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable in the traditional sense of clinical ground truth. Since no clinical study was conducted for efficacy claims relating to hair growth, there were no "experts" establishing a clinical ground truth for a test set of patients.
- The "ground truth" for these tests comes from adherence to international standards (e.g., IEC 60601, IEC 62471, IEC 60825-1). The experts involved would be the test engineers and certification bodies performing and validating the adherence to these specific technical standards. Their qualifications would be in electrical engineering, safety testing, and compliance with the specified standards.
4. Adjudication Method for the Test Set
- None. As this is non-clinical safety and performance testing, there is no need for a clinical adjudication method (like 2+1 or 3+1 consensus). The "adjudication" is simply whether the measured performance passes or fails the pre-defined criteria of the relevant international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for evaluating the performance of AI/CAD systems in medical imaging, often comparing human reader performance with and without AI assistance. This device is a direct-to-consumer LED/Laser helmet for hair growth, not an AI diagnostic tool. Therefore, an MRMC study was neither conducted nor applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No. This device is a physical therapeutic device, not an algorithm. There is no "standalone" algorithm performance to evaluate. The device's performance is its physical output (light wavelength, irradiance, fluence) and safety features, which were tested against engineering standards.
7. The Type of Ground Truth Used
- Engineering and Safety Standards: The "ground truth" for the non-clinical testing is compliance with established international medical device safety and performance standards (e.g., IEC 60601 series, IEC 62471, IEC 60825-1). For biocompatibility, it was established by similarity to a previously cleared predicate device. For software, ground truth was adherence to FDA guidance.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
§ 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.