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The LunulaLaser™ device is indicated for use for the temporary increase of clear nail in patients with onychomyosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

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This document is a 510(k) clearance letter for the LunulaLaser, a Class II medical device. It does not provide information on acceptance criteria or a study that proves the device meets those criteria. Instead, it confirms that the FDA reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indication of temporary increase of clear nail in patients with onychomycosis.

Therefore, I cannot extract the requested information based on the provided text. The document is administrative in nature, approving the device for marketing based on substantial equivalence, rather than detailing a performance study with acceptance criteria.

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The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

Erchonia Allay

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Erchonia Allay", an infrared lamp indicated as an adjunct to reducing chronic heel pain arising from plantar fasciitis.

However, the document is a regulatory approval letter and does not contain the acceptance criteria or any study details that would demonstrate the device meets such criteria. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual study report submitted by Erchonia Medical, Inc. to the FDA as part of their 510(k) submission (K132940).

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The Erchonia® XLR8™ laser is indicated for the following three indications:

• a. adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin
• b. as an adjunct to liposuction procedures of the thighs, hips and stomach for reduction of pain associated with the recovery process
• c. temporary reduction in post-surgery pain at 24 hours after surgery following bilateral breast augmentation surgery

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This document is an FDA 510(k) clearance letter for the Erchonia XLR8TM laser, indicating its intended uses based on substantial equivalence to existing devices. It does not contain information about acceptance criteria or specific study data proving the device meets those criteria. The provided text is a regulatory clearance document, not a detailed study report. Therefore, I cannot extract the requested information from this document.

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The ERCHONIA® Verju™ Laser System with Massager is indicated for use as a non-invasive dermatological aesthetc treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist and thighs.

The Massager component is indicated for the temporary reduction in the appearance of cellulite.

Erchonia® Verju™ Laser System with Massager

This document is an FDA 510(k) clearance letter for the Erchonia® Verju™ Laser System with Massager. It addresses regulatory compliance and substantially equivalent determination but does not contain details about a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information, which typically pertains to studies involving AI/ML device performance. This document is a regulatory approval for a physical medical device (a laser system with a massager) and not an AI/ML diagnostic or therapeutic device.

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The Erchonia PL5000 laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them.

The document is an FDA 510(k) clearance letter for the Erchonia PL5000 device, indicating that the device has been found substantially equivalent to a predicate device. It specifies the "Indications for Use" for the device (temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving the device meets acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information about standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• How ground truth for training data was established.

This document is a regulatory approval notice, not the detailed study report or clinical trial results that would contain the information you are seeking.

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The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.

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This document is a 510(k) clearance letter from the FDA for a medical device called Erchonia® MLS, Zerona™. It primarily communicates the FDA's decision regarding substantial equivalence and regulatory compliance. It does not contain information about acceptance criteria for a study, nor does it describe a study's methodology or results in detail. Therefore, I cannot extract the information required to answer your request.

The letter states the "Indications for Use" for the device, which is "non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms." However, it does not provide acceptance criteria or a study proving that the device meets such criteria.

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For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery.

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This document is a 510(k) clearance letter for the Erchonia EML Laser, indicating that the device has been found substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and performance metrics as they would typically be found in a clinical study report or a more comprehensive premarket submission summary.

The letter only provides the following:

1. Device Name: Erchonia EML Laser
2. 510(k) Number: K072206
3. Indication for Use: "For the temporary reduction in post surgery pain at 24 hours after surgery following bilateral breast augmentation surgery."

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications based solely on the provided text. These details are typically part of the supporting documentation referenced in such clearance letters but are not explicitly presented within the letter itself.

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The Erchonia IOTO_240 is a galvanic generator that is indicated for use in tap water iontophoresis to treat palmer hyperhidrosis and plantar hyperhidrosis.

The Erchonia IOTO_240 is a galvanic generator.

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) premarket notification letter from the FDA regarding the "Erchonia IOTO 240" iontophoresis device. It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance.

However, the document does not contain any information regarding acceptance criteria, study details, device performance data, sample sizes, expert qualifications, adjudication methods, details of a multi-reader multi-case study, standalone algorithm performance, or ground truth establishment relevant to the questions you've asked.

The document primarily focuses on the regulatory approval process and states the intended indications for use, but it does not include the detailed technical and clinical study information you are seeking.

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The Erchonia EVRL Laser is generally indicated:

• while using the red diode, for adjunctive use in providing temporary relief of a. minor chronic neck and shoulder pain of musculoskeletal origin, and
• b. while using the blue diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Erchonia EVRL Laser

This is an incredibly difficult request, as the provided document is a 510(k) clearance letter from the FDA, not a study report or clinical trial results.

A 510(k) clearance signifies that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device, essentially meaning it's as safe and effective as a device already on the market. It does not present the original study data, acceptance criteria, or performance metrics in the format requested.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and performance data for the Erchonia EVRL Laser from this specific document.

However, I can explain why I cannot provide the information from this document and what kind of document would contain it:

• Acceptance Criteria and Reported Device Performance (Table): This information would be found in a clinical study report submitted as part of the 510(k) application, or detailed within the substantial equivalence comparison to the predicate device. The clearance letter itself does not contain these details.

• Sample Size (Test Set) and Data Provenance: This would also be in the clinical study report. The 510(k) letter only indicates the clearance and the date it was received.

• Number and Qualifications of Experts for Ground Truth: This level of detail about ground truth establishment is specifically found within the methodology section of a clinical study report.

• Adjudication Method: Similar to the above, this would be described in the study's methods.

• MRMC Comparative Effectiveness Study: If such a study were performed, its design, methodology, and results (including effect size) would be elaborated in a separate study report. The 510(k) clearance letter does not include this. Given the device's indications, it's unlikely an MRMC study related to human readers would be highly relevant, as it's a laser for pain and acne, not an imaging diagnostic tool.

• Standalone Performance: The 510(k) clearance focuses on substantial equivalence. If standalone performance data was generated, it would be in a study report.

• Type of Ground Truth: The method for establishing ground truth (e.g., expert consensus, pathology, outcome data) would be detailed in the study report. For pain relief, ground truth might involve patient-reported pain scores or physician assessment. For acne, it might involve lesion counts or global assessment scales.

• Sample Size for Training Set: This is typically relevant for machine learning algorithms. While the Erchonia EVRL is a laser device (not explicitly an AI/ML device based on this document), if there were any AI components involved in its use or assessment, that data would be in an AI/ML specific technical report or a clinical study report.

• How Ground Truth for Training Set was Established: Again, this relates to AI/ML development and would be in a technical report or study protocol.

In summary, to answer your request comprehensively, I would need access to the full 510(k) submission, specifically the clinical study reports or summaries of the studies conducted to demonstrate substantial equivalence.

The provided document (K050672) is merely the FDA's decision letter.

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The Erchonia EML is indicated as an adjunct to liposuction procedures of the hips and stomach for reduction of pain associated with the recovery process.

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I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The text is a 510(k) clearance letter from the FDA for a medical device (Erchonia EML Laser) and primarily discusses regulatory aspects such as substantial equivalence, classification, and general controls. It does not include details about device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications.

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