(233 days)
The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.
The Laser hair growth helmet (Model: A-800) is hands-free, portable, non-invasive, low-level laser device, which consists of red visible light diode lasers, to produce red light operating at 650nm wavelength (maximum output power of each is 5mW). The laser sources are arranged in a dot matrix arrangement in the inner of the helmet, which could take into account of every hair follicle and promote rapid hair growth. The device will automatically suspend the work if it is removed from scalp, and the power blue light indicator flashes.
The medical device is the Laser hair growth helmet (Model: A-800), intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II and males with Norwood Hamilton Classifications IIa-V, both with Fitzpatrick Classification of Skin Phototypes I-IV.
1. A table of acceptance criteria and the reported device performance:
The provided document does not contain explicit "acceptance criteria" for clinical performance. Instead, it states that "Clinical performance is not deemed necessary" and focuses on demonstrating substantial equivalence to predicate devices through technical specifications and safety/performance bench testing. The device's performance is therefore reported in terms of its technical characteristics matching or being comparable to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Laser hair growth helmet Model: A-800) |
|---|---|
| Intended Use | The Laser hair growth helmet (Model: A-800) is intended for the promotion of hair growth in females with Ludwig-Savin Classifications I-II, and in males with Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV. (Matches predicates) |
| LLLT Device Type | LLLT |
| Prescription Type | OTC (Matches Predicate II & Reference Device; Predicate I is prescription use) |
| Wavelength | 650nm ± 10nm (Matches all predicates) |
| Laser radiation output | 5mW (Matches Predicate I & Reference Device; Predicate II is 4-5mW) |
| Fluence | 3.03 J/cm² (Comparable to predicates, which range from 1.2 J/cm² to 4.9642 J/cm²) |
| Amount of laser diodes | 180 (Falls within the range of predicates: 36-272) |
| Irradiation over the treatment area | 2.02 mW/cm² (Comparable to Predicate II's range: 2.0857-2.3639 mW/cm²) |
| Classification according to IEC60825-1 | Class 3R (Matches all predicates) |
| Treatment Time (Each Treatment) | 25 min (Comparable to predicates: 20-35 min/30 min) |
| Treatment Time (Total Treatment) | Every two days (Comparable to predicates: every day/every other day) |
| Appearance Design | Helmet cap (Matches predicates: Helmet) |
| Safety and Performance Feature Compliance | Complied with IEC 60601-1, IEC 60601-1-2, IEC 60825-1 |
| Biocompatibility Compliance | All patient contacting materials complied with ISO 10993-5, ISO 10993-10 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test set was used for this submission. The submission explicitly states: "Clinical performance is not deemed necessary." The data provenance for the performance testing is from laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set was used and clinical performance was not deemed necessary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set was used.
5. 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:
Not applicable. This device is a laser hair growth helmet, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical device, not an algorithm, and the submission did not include standalone clinical performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No clinical ground truth was established or used, as no clinical trials were conducted for this submission. The "ground truth" for demonstrating device compliance was based on adherence to recognized international standards for electrical safety, electromagnetic compatibility, laser safety, and biocompatibility, as well as verification and validation for integral software.
8. The sample size for the training set:
Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning algorithm or AI component requiring a training set was part of this device submission.
§ 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.