(83 days)
The SuperGrow 272 laser hat and the Ultimate 272 are 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 to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272. In the Ultimate 272, the SuperGrow 272, is inserted into a dome attached to a stand, and is intended for in-office use.
This document is a 510(k) summary for the SuperGrow 272 and Ultimate 272 devices. It describes the devices, their indications for use, and how they demonstrate substantial equivalence to a predicate device (Capillus272Pro, K163170).
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria related to a clinical outcome or performance metric (e.g., hair count increase, hair thickness increase) are provided in this document. The focus of this 510(k) summary is on non-clinical testing for safety and equivalence to a predicate device.
The reported device performance is related to its adherence to safety standards:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Electrical Safety) | Compliant |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Compliant |
| IEC 60601-1-11 (Home Healthcare Environment) | Compliant |
| IEC 60825-1 (Laser Safety) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical testing (electrical safety, EMC, laser safety) performed on the device itself. It does not involve a "test set" of patient data or clinical outcomes. Therefore, sample size and data provenance in the context of clinical studies are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This 510(k) summary details non-clinical safety and performance testing against established engineering standards, not clinical ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. There's no clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is a Low-Level Laser Therapy (LLLT) device, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical LLLT device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" implicitly refers to the requirements and specifications within the referenced international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60825-1). The device was tested to ensure it met these established safety and performance benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device does not involve a training set for an algorithm.
§ 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.