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510(k) Data Aggregation
(196 days)
LX-100 Hair Growth Stimulation System
The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV
The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.
The provided text is a 510(k) summary for the LX-100 Hair Growth Stimulation System. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets them in the way a clinical trial report would.
Here's an analysis based on the provided document, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" for clinical performance. Instead, it demonstrates technological equivalence to predicate devices in terms of physical characteristics and clinical equivalence based on the predicate devices having already met therapeutic results standards.
| Feature/Characteristic | Predicate Device (K091496 or K122950) Performance (Implied Acceptance Criteria) | LX-100 Hair Growth Stimulation System Performance |
|---|---|---|
| Wavelength (λ) | 650nm (+/-1%) (K091496) or 678nm center (K122950) | 650nm (+/-1%) (644nm to 656nm Measured) |
| Output Per Diode | ≤4.5mW (K091496) or ≤5mW (K122950) | ≤4.5mW Measured |
| Total Output/Dosage (mW/cm2) | .3724 mW/cm2 (K091496) or .4037 mW/cm2 (K122950) | .3802 mW/cm2 |
| Fluence (J/cm2) | .44691 J/cm2 (K091496) or .48446 J/cm2 (K122950) | .45629 J/cm2 |
| Treatment Regimen | 2 - 20 Minute Treatments Per Week, On Non-consecutive Days for 18 or 26 Weeks | 2 - 20 Minute Treatments Per Week, On Non-consecutive Days for 26 Weeks |
| Number of Lasers | 82 (K091496) or 80 (K122950) | 90 |
| Indications for Use | For adjunctive use for the treatment of androgenic (androgenetic) alopecia in females; indicated to promote hair growth of females with Ludwig and Savin Hair Loss Scale classifications of I to II and Fitzpatrick Skin Typing of I to IV | Same as predicate devices, but for 26 weeks. |
| Safety | Compliance with laser safety regulations (Class Illa; IIIr) and safety features (key lock, interlock, head proximity safety). | Full Compliance (Class Illa; IIIr) and similar safety features. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a new clinical study. It relies on the equivalence to previously approved devices. Therefore, there is no "test set" in the sense of a new patient cohort for the LX-100. The performance is based on the established performance of the predicate devices. There is no specific data provenance mentioned in terms of country of origin or retrospective/prospective for a study of the LX-100 itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as no new clinical study to establish performance for the LX-100 is presented. The "ground truth" for the efficacy of low-level laser therapy for androgenetic alopecia in females is implied to have been established by the predicate devices' approval through their own studies.
4. Adjudication Method for the Test Set
Not applicable as no new clinical study to establish performance for the LX-100 is presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not described or implied in the document, as it focuses on demonstrating substantial equivalence based on technological and intended use similarities to existing devices, not on comparing performance with and without AI assistance or human reader improvement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the LX-100, as it is a physical medical device (a hair growth stimulation system) and not an AI algorithm. Its performance is inherent to its physical operation and biological effect, not an algorithmic output requiring standalone evaluation.
7. The Type of Ground Truth Used
For the LX-100, the "ground truth" for its acceptance is based on its substantial equivalence to existing legally marketed predicate devices. The efficacy and safety claims of low-level laser therapy for androgenetic alopecia in females, which the LX-100 aims to meet, were presumably established by the predicate devices through clinical trials (pathology, clinical observable outcomes, or other relevant data for hair growth). The current document does not detail the specific ground truth used in those predicate studies.
8. The Sample Size for the Training Set
Not applicable. The LX-100 is a hardware device; it does not utilize a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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