(59 days)
Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.
This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Breo Laser Hair Growth Comb (Scalp 3L)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for a novel AI/medical device.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI algorithm performance or direct clinical efficacy studies with specific metrics) are not present in the provided text. The document states "Clinical study: Not applicable" (Section 9), indicating that a clinical trial to prove efficacy or safety in the traditional sense was not required for this 510(k) clearance due to the device's similarity to an already cleared predicate.
Here's what can be extracted and what cannot:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device (Laser Therapy Hair Growth Comb, Lasercomb-001, K230134). This means the device performs similarly in terms of its technical specifications and intended use.
| Acceptance Criterion (Implicitly Met by Equivalence) | Reported Device Performance (Subject Device: Breo Laser Hair Growth Comb Scalp 3L) | Predicate Device Performance (Lasercomb-001) |
|---|---|---|
| Intended Use/Indications for Use: Treatment of Androgenetic Alopecia, promotion of hair growth in specific Ludwig (Savin) classifications for females and Norwood Hamilton classifications for males, both with Fitzpatrick Skin Types I to IV. | Same | Same |
| Location for Use: OTC application | OTC application | OTC application |
| Type of Laser: Visible red light-emitting diodes | Visible red light-emitting diodes | Visible red light-emitting diodes |
| Wavelength: 650nm ± 10nm | 650nm ± 10nm | 650nm ± 10nm |
| Amount of Laser Diodes: 7 | 7 | 7 |
| Energy per Laser Diode: |
§ 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.