(87 days)
The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton 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-1, II-2; both with Fitzpatrick Skin Types I to IV.
The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device utilizes 40 laser diodes 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 is complete.
The provided document K180460 is a 510(k) Premarket Notification by Theradome, Inc. for their Theradome LH40 (Theragrow) device. This document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use, specifically to include male pattern baldness.
Crucially, the document states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." and "Performance testing was not required to support a substantial equivalence determination for the Theradome LH40 device."
Therefore, based on the provided text, there is no detailed information about acceptance criteria or a specific study proving the device meets those criteria through performance testing or clinical trials. The FDA's substantial equivalence determination for this submission was based on the device having the same technological characteristics and intended use as previously cleared devices.
Here's an breakdown of the requested information based only on the provided document:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
Since no new performance or clinical data was required for this specific submission, the "acceptance criteria" here refers to the device's technological characteristics being equivalent to the predicate devices and fitting its expanded indications for use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Theradome LH40 - K180460) |
|---|---|
| Primary Indication: | Expanded Indication: |
| Treat Androgenetic Alopecia and promote hair growth in males (Norwood-Hamilton IIa to V) who also have Fitzpatrick Skin Types I to IV. | The device is intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and also have Fitzpatrick Skin Types I to IV. |
| Secondary Indication: | Existing Indication (via predicate): |
| Treat Androgenetic Alopecia and promote hair growth in females (Ludwig-Savin I-1 to I-4, II-1, II-2) who also have Fitzpatrick Skin Types I to IV. | The device also retains the existing indication for treating Androgenetic Alopecia and promoting hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV. |
| Technological Characteristics: | Demonstrated Equivalence: |
| Number of Laser Diode | 40 |
| Laser Class | Class 3R |
| Laser Power | 5mW |
| Wavelength (nm) | 678 (+7) |
| Laser Delivery Method | Helmet |
| Helmet Design | Helmet |
| Single Button Operation | Yes |
| Audible Timer | Yes |
| Treatment Time and Duration | 1200 sec (20 min) per session, 4 times/week |
| Materials of Construction | Unchanged from predicate |
| Risk Profile | Unchanged from predicate |
| Battery Operation | Yes |
Study Details (or lack thereof, based on provided document)
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Sample size used for the test set and the data provenance:
- N/A. The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the Theradome LH40 device." This means no new clinical test set was used for this specific submission. The determination was based on equivalence to predicate devices, which would have had their own clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. No new test set, thus no new ground truth establishment by experts for this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No new test set.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a low-level laser therapy (LLLT) helmet for hair growth, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware device, not an algorithm, and no new standalone performance study was conducted for this submission.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No new ground truth data was generated for this specific submission. The substantial equivalence is based on the predicate devices' previously established safety and effectiveness, which would have involved clinical outcomes data or other relevant methods to establish their initial ground truth.
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The sample size for the training set:
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- N/A. Not applicable for this type of device and submission.
Summary of the K180460 Submission:
This 510(k) focuses on a "substantial equivalence" claim. The submitter successfully argued that the Theradome LH40 (Theragrow) device, for its expanded indications to include male pattern baldness, is essentially the same as its own previously cleared devices (K161046 Theradome LH40 Evo and K171775 Theradome LH80 Pro) in terms of technology, operation, and safety profile. Because the core technological characteristics were unchanged from its predicate, and the expanded indication falls within a similar scope to what was previously cleared (promoting hair growth for Androgenetic Alopecia), the FDA determined that new performance data or clinical trials were not necessary for this specific 510(k) clearance.
§ 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.