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The Bosley Revitalizer 96 Laser Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

The Bosley Revitalizer 96 Laser Cap consists of 96 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. Just as with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.

The provided text is a 510(k) Premarket Notification summary for the Bosley Revitalizer 96 Laser Cap. Based on the document, this is a Special 510(k) submission, meaning the device is a modification of a previously cleared device. Therefore, a new, independent clinical study to prove efficacy and safety against new acceptance criteria was not performed. Instead, the submission relies on the substantial equivalence to predicate devices and verification/validation activities to confirm that the modifications do not introduce new risks or significantly alter performance compared to the original design.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state numerical acceptance criteria for a new clinical study. Instead, it relies on the safety and efficacy of its predicate devices. The "performance" assessment is primarily focused on confirming that the modified device (with fewer diodes) still meets established safety standards and that its reduced "dose" is acceptable given the intended indefinite use and lower cost.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

No new clinical study was conducted for this Special 510(k) submission. The performance assessment relied on verification and validation activities of the modified device and comparison to previously cleared predicate devices. Therefore, there is no "test set" in the context of a new clinical efficacy study, nor explicit sample size or data provenance from such a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as no new clinical study requiring ground truth establishment was conducted for this Special 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study requiring adjudication was conducted for this Special 510(k) submission.

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. The device is a laser cap for hair growth, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a hardware device for hair growth, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new clinical study requiring ground truth was conducted for this Special 510(k) submission. The efficacy claims for the predicate devices would have been based on clinical trials measuring hair growth (e.g., hair count, global photographic assessment), but details of those specific ground truths are not provided in this document.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted. No "training set" in the context of AI or a new clinical trial is mentioned.

9. How the ground truth for the training set was established

Not applicable, as no new clinical study was conducted.

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The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV.

The BOSLEY Revitalizer 272 and 164 Laser Caps are low level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 or 164 visible red light-emitting diodes at 650-nm and 5mW each. The lasers are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes.

The provided text describes a 510(k) submission for the BOSLEY Revitalizer 272 and 164 Laser Caps. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device were primarily related to OTC/Usability Testing and Biocompatibility.

• Material must not be a sensitizer for skin contact. | - Cytotoxicity tests demonstrated that the material used in the manufacturing of the caps is non-cytotoxic. The caps met the requirements of ISO 10993-1:2009, ISO 14971:2007, and FDA General Program Memorandum #G95-1, for surface devices with limited contact (

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The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.

The illumiflow Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.

The provided text describes the regulatory clearance for the "Illumiflow Laser Cap." However, it does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system for a medical imaging device.

The document is a 510(k) summary for a low-level laser therapy (LLLT) device intended to promote hair growth. The studies mentioned are primarily:

• Biocompatibility testing: To ensure materials are safe for patient contact.
• Non-clinical performance testing: To confirm compliance with design specifications and electrical safety/EMC standards (e.g., IEC 60825-1, IEC 60601-1).
• Usability testing: To confirm that lay users can understand labeling and use the device safely and correctly.

There is no mention of:

• A table of acceptance criteria for diagnostic/AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used to evaluate AI performance.
• Data provenance for such test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness with human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set details (size, ground truth establishment).

The device is a direct-to-consumer therapy device, not a diagnostic imaging device utilizing AI. Therefore, the detailed AI-related study information you requested is not present in this document.

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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 HairMD is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa-V and for both, Fitzpatrick Classification of Skin Phototypes of I-IV.

The HairMD consists of 21 red, visible-light, continuous wave diode lasers operating at 650 nanometers and 30 super luminescent light emitting diodes (LEDs), operating at 650 nanometers that are configured within a protective inner liner and outer helmet. The HairMD is physically similar to the iGrow Hair Growth System, except that it does not contain earphones or inner liner spacers. The use of these specific number of diode lasers and LEDs, 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 re-established. 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 line voltage, operating at 110/220 volts.

The provided text describes a 510(k) premarket notification for the HairMD device, an infrared lamp intended to promote hair growth. However, it explicitly states that "No clinical trial data for the HairMD was submitted for this 510(k)." Therefore, a study proving the device meets acceptance criteria, as well as several of the requested data points (like sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and training set details), are not available in this document.

The submission focuses on demonstrating substantial equivalence to predicate devices (iGrow Hair Growth System and Hairmax Lasercomb) based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or clinical performance data for the HairMD device. It states: "No clinical trial data for the HairMD was submitted for this 510(k)."

However, it does mention that the device was tested for conformance with safety standards.

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not applicable, as no clinical trial data was submitted.
• Data Provenance: Not applicable, as no clinical trial data was submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as no clinical trial data was submitted and thus no ground truth for a test set was established.

4. Adjudication method for the test set

• Not applicable, as no clinical trial data was submitted.

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

• No MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool; it's a therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a therapeutic device, not an algorithm.

7. The type of ground truth used

• Not applicable, as no clinical trial data was submitted. The substantial equivalence argument relies on the established safety and efficacy of the predicate devices and the HairMD's comparable technological characteristics.

8. The sample size for the training set

• Not applicable, as no clinical trial data was submitted for the HairMD device itself. The device is not based on a machine learning model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable (see point 8).

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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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