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Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.

The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head i.e., the area commonly covered with stylized hair. The LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip.

The provided text is a 510(k) summary for the LaserCap Family of Lasers, models 300, 224, 120, and 80, seeking Over-The-Counter (OTC) clearance for devices previously cleared for prescription-use. The core argument for substantial equivalence relies on the fact that the proposed OTC devices are identical to the previously cleared prescription-use predicate devices in their design, function, and performance. Therefore, no new clinical performance data or testing was performed for this submission.

This means that the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, because such studies were deemed unnecessary due to the device's substantial equivalence to already cleared devices.

The document explicitly states:

• "No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates..." (Page 4)
• "No OTC testing was performed for this submission because the User Manual and packaging contents for the predicates and reference devices, are substantially equivalent to the Reference Devices." (Page 5)
• "Biocompatibility, electrical safety and EMC testing is not needed in this submission because the subject device is identical to the predicate devices in these aspects." (Page 6)

In summary, the provided text does not include the details of a study that proves the device meets acceptance criteria in the way typically expected for a new or novel device. Instead, it relies on the established safety and efficacy of its identical predicate devices. Therefore, I cannot construct the requested table or answer most of the questions, as the information is not present in the provided context.

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LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopeda who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of lla-V and for both, Fitzpatrick Skin Phototypes I to IV.

LaserCap300, LaserCap224, LaserCap120, and LaserCap80 consist of red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. The devices only vary in number of lasers (300, 224, 120, and 80 diodes, respectively) and LaserCap300 has a small extension of the LaserCap housing perimeter where its additional laser diodes target peripheral hair-bearing areas of the scalp. 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 (1 short beep) or ended (one long beep). The portable systems are powered by rechargeable Li-lon battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.

The provided text describes the regulatory filing for the "LaserCap" family of devices (LaserCap300, LaserCap224, LaserCap120, LaserCap80) for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study to prove new acceptance criteria.

Therefore, the information you requested about acceptance criteria met by a specific study is not directly available in the provided text as the application relies on proving similarity to already approved devices.

However, I can extract information related to the device's performance based on the substantial equivalence argument, which implies that the device meets the same safety and effectiveness standards as the predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating sameness to predicate devices that have already met regulatory standards. The reported device performance is therefore described in terms of its technological characteristics matching, or being acceptably similar to, predicate devices.

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The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.

The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells pack and charger are fully compliant to recognized, international standards.

This document describes a 510(k) premarket notification for the LaserCap LCPro and LCElite devices. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they relate to clinical studies that were not performed or submitted for this 510(k).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific performance metrics (e.g., hair growth percentage, hair count increase) from a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

However, it does state an Intended Use / Indications for Use:
"The LCPro and LCElite are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV."

Device Characteristics provided:

The performance data states: "No Clinical trial data for LCPro and LCElite were submitted for this 510(k)."

2. Sample size used for the test set and the data provenance: Not applicable – No clinical trial data was submitted or referenced as a test set for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable – No clinical trial data was submitted or referenced, so no ground truth establishment by experts is detailed for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable – No clinical trial data was submitted or referenced, so no adjudication method for a test set is detailed.

5. 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 device is a low-level laser therapy device for hair growth, not an AI-assisted diagnostic or therapeutic device for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable – This device does not involve an algorithm or AI for standalone performance evaluation in the context described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable – No clinical trial data requiring ground truth for performance evaluation was submitted.

8. The sample size for the training set: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

9. How the ground truth for the training set was established: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

Summary of the document's approach to "proving" the device meets criteria:

Instead of a clinical study demonstrating acceptance criteria, the 510(k) application for the LaserCap LCPro and LCElite relies on the concept of substantial equivalence to legally marketed predicate devices.

The document indicates the following about how the device "meets acceptance criteria" (in the context of substantial equivalence):

• Technological Characteristics: The LCPro and LCElite utilize similar technological characteristics (red light diode lasers, 650 nm wavelength) to the predicate devices (Capillus272 Pro and Theradome LH 80 Pro). The LCPro uses pulsed emission similar to Capillus272 Pro, and the LCElite uses continuous emission similar to Theradome LH 80 Pro.
• Energy and Irradiance Output: The devices provide "similar energy and irradiance output to the treatment area" as their respective predicates.
• Intended Use: The intended use of promoting hair growth in females with androgenetic alopecia (Ludwig-Savin Classifications I-II, Fitzpatrick Skin Phototypes I-IV) is the same as the predicate devices.
• Safety and Effectiveness: The sponsor believes that "the differences between the subject devices of this 510(k) compared with the predicate devices, do not substantially affect the therapeutic value or the safety profile."
• Standards Conformance: The devices were tested for conformance with several international standards: IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133. This demonstrates basic electrical safety and electromagnetic compatibility compliance, which are general controls for medical devices.

In essence, the "proof" for this 510(k) is the demonstration that these new devices are sufficiently similar to already cleared devices that they are considered substantially equivalent, implying they carry the same level of safety and effectiveness as the predicates without the need for new clinical data.

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