(135 days)
The Theradome Laser Helmet LH80 PRO is intended to treat androgenic alopecia by promoting hair growth.
The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopedia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.
The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes laser diodes in the heimet to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.
The provided text is a 510(k) summary for the Theradome Laser Helmet LH80 PRO. It describes the device, its intended use, indications for use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, especially in terms of clinical performance or a multi-reader multi-case study.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- Type of Device: The Theradome Laser Helmet LH80 PRO is a low-level laser therapy (LLT) device intended to promote hair growth. This type of device typically relies on clinical studies to demonstrate efficacy, but this document does not present such a study.
- Focus of the Submission: The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (RF Midwest LLC MEP-90 Hair Growth Stimulation System K091496) based on technological characteristics, intended use, and indications for use.
- "Performance Characteristics" Section: This section mentions "Testing to IEC 60601-1 and 60601-1-2 confirm the device's safety and electrical compatibility" and "Testing to IEC 60825-1 certifies the laser system to classification 3R, same as predicate device." It also states, "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." These are safety and engineering performance tests, not clinical efficacy studies with specific acceptance criteria as you've outlined.
Given the limitations of the provided text, I can only address the questions where information is explicitly available or directly inferred.
Acceptance Criteria and Study for Theradome Laser Helmet LH80 PRO
The provided 510(k) summary does not disclose specific clinical acceptance criteria for hair growth efficacy or a study proving those criteria. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through safety, electrical compatibility, and laser classification testing, rather than an independent clinical efficacy trial with predefined performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Clinical Efficacy | (Not Specified) | (Not Specified) | (Not specified in this document) |
| Safety (Electrical) | Adherence to IEC Standard | IEC 60601-1 | Confirmed to comply |
| Safety (Electromagnetic Compatibility) | Adherence to IEC Standard | IEC 60601-1-2 | Confirmed to comply |
| Safety (Laser Classification) | Adherence to IEC Standard | IEC 60825-1 Classification 3R | Certified to Classification 3R (same as predicate) |
| Design Specifications | Functional Operation | All functions operate as designed | Confirmed to comply |
Note: The 510(k) summary explicitly states "Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed." This refers to engineering and functional performance, not clinical outcome performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not mentioned for clinical efficacy. The performance tests mentioned (IEC standards, design specifications) are typically conducted on a limited number of device units for engineering verification, not a clinical "test set" in the context of patient data.
- Data Provenance: Not applicable for clinical data. The mentioned tests are engineering/safety in nature and would be conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The document does not describe a clinical study requiring expert assessment for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The document does not describe a clinical study or expert review process that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC study was not described or conducted, as this device does not involve image interpretation or diagnostic performance that would necessitate such a study.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Was a standalone study done? Not applicable. This device is a therapeutic (LLT) device, not an AI algorithm. Its performance is directly tied to its physical operation and biological effect, not an algorithmic interpretation task.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical efficacy. For the safety and performance tests mentioned (IEC standards, design specifications), the "ground truth" would be the engineering specifications and compliance requirements of the respective standards.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device does not involve machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
§ 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.