(80 days)
The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.
The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.
The HairMax LaserComb 41 (HMLC 41) and HairMax LaserComb 82 (HMLC 82) are low-level laser devices that provide distributed laser light to the scalp while comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The HMLC 82 device emits 82 laser beams with wavelengths of 655 nm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The HMLC 41 device emits 41 laser beams with wavelengths of 655 mm (+/- 10 nm), spaced at 7mm intervals and has a total laser module output within the limitation of a Class 3R laser. The laser diode modules used in the HMLC 41 & 82 are identical to those used in their predicate devices.
As with the predicate device, the HMLC 41 & 82's lasers are contained in between hair parting teeth that push the hair aside, allowing the optimum amount of laser energy to reach the scalp, as the user passes over the scalp. The hair parting teeth move the hair aside and allow an unobstructed path of laser energy to the scalp.
At the beginning of a treatment session, the device is placed in the first position on the scalp (the first 7.5cm scalp section, closest to the forehead) and will rest here for the intended treatment time. As with the predicate devices, the HMLC 41 & 82 will use a short vibration to advise the user it is time to move to the next scalp location. The HMLC 41 & 82 will maintain contact with the scalp allowing the hair parting teeth to part the hair as the user moves the device backwards, combing the hair, along the scalp to the second position. The teeth are necessary to part the hair and provide an unobstructed path for the laser light to reach the scalp. The device will remain in the second position until the vibration informs the user to move to the third position. Similar indication and movement will continue for three positions to cover the entire area of hair loss on the scalp. The lasers will automatically turn off after the intended treatment duration.
The units operate from an internal, rechargeable lithium polymer battery. The LiPoly battery is charged from a Class 2, UL, and CUL rated wall transformer at 6VDC and 1000mA. In the event of a power failure, the laser control circuitry is designed to disable the laser diodes until reactivated by the control switch. The devices include battery monitoring and charging circuitry which ensure the effective delivery of optimal laser energy output during the treatment time. The devices include a proximity sensor and will not allow the lasers to be turned on unless in contact with the scalp.
The provided text describes the HairMax LaserComb 41 and HairMax LaserComb 82 devices and their substantial equivalence to previously cleared predicate devices (HairMax LaserComb Lux 9, K110233 and K103368). The submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for safety and effectiveness from scratch. Therefore, the information provided focuses on demonstrating that the new devices are as safe and effective as the predicate.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for a new study are not presented in the typical sense of a clinical trial with primary and secondary endpoints. Instead, the performance is evaluated against the predicate device’s established safety and efficacy. The criteria primarily relate to maintaining the same technological characteristics and output as the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety: | |
| - Laser safety (Class 3R operation) | - Confirmed per IEC60825-1:2007, Condition 1 and Condition 2. |
| - Electrical safety (e.g., battery, charger) | - Internal, rechargeable lithium polymer battery. Charged by Class 2, UL, CUL rated wall transformer (6VDC, 1000mA). Battery monitoring and charging circuitry ensure effective laser energy delivery. |
| - Accidental laser activation prevention | - Laser control circuitry disables diodes on power failure. Proximity sensor prevents laser activation unless in contact with the scalp. |
| Effectiveness/Performance: | |
| - Laser output parameters and dose rate | - Verified against the predicate device using Ophir 7Z01560, Serial # 544640 (calibrated April 2014). Laser output levels were substantially the same as the predicate (within +/-10% tolerance). HMLC 41 & 82 use identical laser modules as the predicate, confirmed by module specifications and Certificate of Compliance (wavelength, divergence, power). |
| - Hair growth promotion (implied from predicate equivalence) | - "The results of the testing demonstrate that the modified devices (HMLC 41 & 82) operated as intended and are as safe and effective as the predicate device." The predicate device was cleared for treating Androgenetic alopecia and promoting hair growth. |
| - Intended use/indications | - Same as for the HairMax LaserComb Lux 9 (HMLC Lux 9) cleared pursuant to K103368 and K110233. (Specifically: treat Androgenetic alopecia and promote hair growth in males (Norwood Hamilton Classifications IIa to V) and females (Ludwig (Savin) Scale I-4, II-1, II-2, or frontal), both with Fitzpatrick Skin Types I to IV.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench testing to demonstrate performance and safety. It does not mention a clinical "test set" in the sense of human subjects with a specified sample size. The "data provenance" is from laboratory measurements and comparisons to the predicate device's established characteristics. There is no indication of country of origin for a clinical data set or whether it’s retrospective or prospective, as no new clinical study (involving human subjects) is described for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this submission. The ground truth for proving substantial equivalence here relies on bench test measurements against engineering specifications and comparison to a predicate device, rather than expert clinical consensus on a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no human-adjudicated "test set" in the context of this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This submission focuses on demonstrating substantial equivalence through technological comparison and bench testing, not through new clinical trials with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is not an algorithm; it is a physical medical device. Therefore, a standalone algorithm performance study is not applicable. The device's "standalone" performance relates to its physical operation and outputs as measured in bench testing.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Bench test measurements: Laser output parameters, dose rate, electrical characteristics.
- Engineering specifications: Conformance to IEC60825-1:2007 for laser safety, and internal product specifications for laser modules (wavelength, divergence, power levels).
- Regulatory precedent: The safety and effectiveness data of the legally marketed predicate devices (HairMax LaserComb Lux 9, K110233 and K103368) forms the foundational "ground truth" that the new devices are compared against for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes a 510(k) submission based on substantial equivalence, not the development of a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in this context.
§ 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.