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510(k) Data Aggregation
(45 days)
Capillus 112, Capillus 244
The Capillus X and Capillus X+ laser domes are intended to treat Androgenetic Alopecia and promotion of hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and treating Androgenetic Alopecia and promotion of hair growth in females who have Ludwig (Savin) Scale 1-4, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The CapillusX and CapillusX+ consist of 112 and 244 (respectively) red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter. These models are exactly the same as the (predicate) Capillus family of devices (CapillusPro, Capillus202, Capillus82) with the exception of the number of diodes. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack and charger are fully compliant to recognized, international standards.
This document describes the FDA's clearance of the CapillusX and CapillusX+ devices, which are low-level laser therapy (LLLT) devices intended for the treatment of androgenetic alopecia and promotion of hair growth. The information provided primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly laid out as a table of clinical performance metrics that need to be met by a new study, but rather focus on demonstrating compliance with safety standards and showing equivalence to predicate devices, for which efficacy has already been established. The performance data presented refers to the device meeting design specifications and safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to design specifications | All functions have been verified to operate as designed. All acceptance criteria were met by the device. |
| Conformity to IEC 60825-2007-03 standard for laser safety | The CapillusX+ conforms to the standard IEC-602825-2007-03. This report validates the laser class of 3R, which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. |
| Conformity to IEC 60601-1 standard for medical electrical equipment (charger) | The charger conforms to IEC 60601-1. |
| No new safety or efficacy concerns compared to predicate devices | "There are no reported adverse events for this technology." "The CapillusX and CapillusX+ are as safe and effective as the predicate devices, as well as other reference devices in its class." "No new safety or efficacy concerns are raised due to the minor differences present between devices." |
| Maintain Class 3R laser classification (5mW max) | Both CapillusX and CapillusX+ contain laser diodes classified as Class 3R, with a 5mW maximum per diode, consistent with predicate devices. Total energy output shown as 560mW/1220mW max energy for CapillusX/X+. |
| Intended Use Equivalence | Intended Use: Treat Androgenetic Alopecia and promote hair growth in males (Norwood Hamilton Classifications of IIa to V) and females (Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal); both with Fitzpatrick Skin Types I to IV. This is identical to the predicate device's intended use. |
| Over-the-Counter Use | Consistent with predicate devices. |
| Marketing Clearance for Males and Females | Consistent with predicate devices. |
| Passive Use-Hands Free | Consistent with predicate devices. |
| Fitzpatrick Skin Phototypes I-IV | Consistent with predicate devices. |
| Ludwig-Savin I-II (females) / Norwood Hamilton IIA-V (males) | Consistent with predicate devices. |
| Device Class II | Consistent with predicate devices. |
| Adverse Event Profile | "Just as for the currently cleared Capillus family of devices, there are no reported adverse events for this technology." |
| Efficacy Rates (Comparison to Predicate) | CapillusPro: "Efficacy Rates - High Compared to Placebo." Capillus82: "Same as for MEP-90 (predicate)." CapillusX/X+: "Efficacy Rates - 35-48% (calculated)." |
| Note: The document implies these efficacy rates are a calculation based on the established efficacy of similar devices, not from a new clinical study for the CapillusX/X+ themselves. |
2. Sample Size Used for the Test Set and Data Provenance
No new clinical study with a specific "test set" was conducted for the CapillusX and CapillusX+ devices to prove clinical efficacy. The submission relies on demonstrating substantial equivalence to predicate devices (CapillusPro, Capillus82, and implied reference to MEP-90) for which efficacy was previously established. The performance data mentioned (compliance to design specifications and safety standards) does not involve a human clinical test set in the conventional sense. The provenance of adverse event data is implied to be from existing post-market surveillance of the substantially equivalent predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable, as no new clinical study requiring ground truth establishment by experts for a test set was performed for the CapillusX/X+ devices themselves. The submission leverages the prior findings for predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical study requiring adjudication of a test set was performed.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC study was reported for the CapillusX or CapillusX+. The submission is based on substantial equivalence, not on demonstrating improved human reader performance with AI assistance, as these devices are LLLT products, not AI-powered diagnostic tools.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The devices are standalone LLLT devices for patient use, not algorithms providing a diagnostic output that would be evaluated in a standalone manner. The device's "performance" refers to its physical output (laser emission) and safety, not an algorithmic interpretation.
7. The Type of Ground Truth Used
For the CapillusX and CapillusX+, the "ground truth" for proving safety and efficacy is not related to a new clinical study. Instead, it relies on:
- Compliance with recognized electrical and laser safety standards (IEC 60825-2007-03 and IEC 60601-1).
- Demonstration of substantial equivalence to previously cleared predicate devices which had, presumably, established their efficacy and safety through clinical trials or other accepted methods at the time of their clearance. The "Efficacy Rates - 35-48% (calculated)" for CapillusX/X+ are derived from the established efficacy of the predicate technology, not from new clinical outcomes data specifically for these models.
- Absence of reported adverse events from existing market experience with the predicate technology.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm development (which would involve a training set) is described for these LLLT devices.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no machine learning algorithm development (which would involve a training set and ground truth for that training) is described.
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