(69 days)
The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
The easy Hairfull consists of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system automatically pauses therapy when the device is not in the correct head position and resumes treatment when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and the device will automatically turn off.
The device could be powered by internal rechargeable li-on battery, and it can also be supplied by specified external adapter with Input AC 100-240V, 50/60Hz and Output DC 5V, 2A.
The easy Hairfull device, an infrared lamp for hair growth, received 510(k) clearance based on its substantial equivalence to a predicate device, Hair Up (K180617). The submission refers to non-clinical tests to demonstrate device performance and safety, but does not include any information regarding a clinical study assessing the device's efficacy in promoting hair growth, nor does it provide specific acceptance criteria or reported device performance metrics related to hair growth from such a study.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific performance acceptance criteria or reported device performance results related to hair growth efficacy. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and adherence to safety standards.
The table below summarizes the technical characteristics compared to the predicate device, which implies that matching these characteristics was the "acceptance criteria" for demonstrating substantial equivalence and thus clearance.
| Acceptance Criteria (Technical Characteristic) | easy Hairfull Performance (Proposed Device) | Predicate Device (Hair Up, K180617) Performance | Device Meets Acceptance Criteria? |
|---|---|---|---|
| Manufacturer | Y&J BIO Co., Ltd. | Y&J BIO Co., Ltd. | Yes |
| Device Name | easy Hairfull | Hair Up | N/A (different name) |
| Classification / Regulation | Class 2 / 890.5500 | Class 2 / 890.5500 | Yes |
| Product Code | OAP | OAP | Yes |
| Intended Use | Promote hair growth in specific androgenetic alopecia classifications (males IIa-V, females I-II) and Fitzpatrick Skin Phototypes I-IV | Promote hair growth in specific androgenetic alopecia classifications (males IIa-V, females I-II) and Fitzpatrick Skin Phototypes I-IV | Yes |
| Mode of Operation | Low-level laser diodes and light emitting diodes | Low-level laser diodes and light emitting diodes | Yes |
| Wavelength | 655 nm | 655 nm | Yes |
| Number of LDs/LEDs | LDs: 21, LEDs: 30 | LDs: 21, LEDs: 30 | Yes |
| Electrical Requirements (Input) | AC 100V ~ 240V, 50Hz/60Hz, 5V 2A | AC 100V ~ 240V, 50Hz/60Hz, 5V 2A | Yes |
| Battery Type | li-on battery | li-on battery | Yes |
| How to use | Helmet system | Helmet system | Yes |
| Treatment time | Each 20-25 min, every two days for 16 weeks | Each 20-25 min, every two days for 16 weeks | Yes |
| Maximum Power | 5mW | 5mW | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe an efficacy clinical study using a test set of human subjects for evaluating hair growth. The "Performance Data" section refers to non-clinical tests regarding wavelength, output power, safety, electromagnetic compatibility, photobiological safety, risk management, and usability, all performed on the device itself, not on human subjects for efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Since no human test set was described for efficacy evaluation, there is no mention of experts establishing ground truth for such a test. The evaluation for market clearance was based on substantial equivalence for technical and safety parameters.
4. Adjudication Method for the Test Set
Not applicable. No human test set for efficacy evaluation was described.
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 not an AI-powered diagnostic or assistive technology for human readers. It's a therapeutic device using light to promote hair growth.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As mentioned, this is a therapeutic device, not an algorithm, and the provided document does not include a standalone performance study in a clinical context for efficacy. The "Performance Data" section lists non-clinical tests performed on the device in a standalone manner (e.g., measurement of wavelength, power output), but these are not for efficacy.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the safety and technical performance data presented (non-clinical tests), the "ground truth" would be established by physical measurements, engineering standards, and regulatory requirements (e.g., IEC standards, 21 CFR regulations).
For the intended use (promoting hair growth), the document does not present any efficacy data or associated ground truth. The clearance is based on the device being substantially equivalent to a previously cleared device (Hair Up K180617) which presumably had its efficacy established in prior submissions (though details of that are not in this document).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.