Search Results

The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);

The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.

There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.

The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.

The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.

However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:

Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)

Regarding the AI/SaMD specific questions from your prompt:

1. Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Dermatological Diode Laser (Model: Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.

The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair.

The provided text is a 510(k) summary for the Hakon and Hakon Smart dermatological diode laser for hair removal. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Unfortunately, the document does not contain the requested information regarding acceptance criteria and the results of a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The document states:

• "No clinical trial was performed."
• The "Non-Clinical Evaluation (Performance and Safety Evaluation)" section refers to compliance with recognized international regulations and standards for safety and electrical compatibility (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1). These standards primarily address the physical and electrical safety of the device, not its clinical effectiveness or specific performance metrics related to hair reduction beyond its intended use as a laser.
• The device is a laser surgical instrument, not an AI-based diagnostic or treatment planning system that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or clinical effectiveness studies in the format requested, as this information is not present in the provided text.

The document focuses on establishing substantial equivalence to a predicate device (K210663) based on:

• Indications for Use: Identical for both devices (permanent hair reduction on all Fitzpatrick skin types).
• Technological Characteristics: Similar principle of operation (diode laser), class, product code, and safety standards. There are some observed differences in spot size, fluency, pulse duration, power supply, dimensions, and weight, but the submitter argues these differences do not compromise efficiency, effectiveness, or safety.

In summary, none of the requested information regarding AI/algorithm performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies is available in the provided text. The device is a physical laser instrument, and its evaluation in this document focuses on engineering and regulatory compliance standards rather than algorithmic performance.

Ask a specific question about this device