Search Results
Found 1 results
510(k) Data Aggregation
(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: < 5mW | 4.89 mW (< 5mW) | 4.63 mW, 4.56 mW, 4.66 mW, 4.78 mW, 4.86 mW, 4.78 mW (implicitly < 5mW) |
| Laser Classification (IEC 60825-1): Class 3R | Class 3R | Class 3R |
| Treatment Time: 15 min per treatment | 15 min per treatment | 15 min per treatment |
| Treatment Frequency: 3 times per week, spaced every other day, as little as 16 weeks | 3 times per week, spaced every other day, as little as 16 weeks | 3 times per week, spaced every other day, as little as 16 weeks |
| Applicable People (Hair Loss Classification): Norwood-Hamilton IIa | Norwood-Hamilton IIa | Norwood-Hamilton IIa |
| Applicable Skin: Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV | Fitzpatrick Skin Phototypes I-IV |
| Shape Design: Comb | Comb | Comb |
| Safety Features (Compliance): IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60825-1, IEC 62133 (Battery) | Complied with listed standards | Complied with listed standards |
| Biocompatibility: All body contacting materials compliant with ISO 10993-5, -10, -23 | Complied with listed standards | Complied with listed standards |
| Electrical Safety & EMC: Compliance with specified standards | Passed specified standards | Passed specified standards |
Study Details (Based on the Provided Document)
As noted, the document explicitly states "Clinical study: Not applicable." The demonstration of the device meeting acceptance criteria is primarily through the comparison of technical specifications and safety standards compliance to a legally marketed predicate device. Therefore, many standard questions about AI/medical device study design are not applicable here.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is described for efficacy. Safety testing (biocompatibility, electrical safety, EMC) is done on the device itself, not on a human population test set for efficacy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic or therapeutic device that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for effectiveness/clinical performance. For safety and functional performance, the "ground truth" is compliance with established international standards (IEC, ISO) and the comparable performance of the predicate device.
- The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/machine learning device requiring such.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1