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The Laser Treatment System 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 Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.

The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, delivery system, control system, cooling system, laser system.

The models object of this submission are Armo and Hera:

Hera has one handpiece connector.

Armo has two handpiece connectors.

The 808 nm handpieces with different spot sizes (3 spot sizes : 12×12mm,12×20mm,15×27m) are available for both models.

The provided text describes a 510(k) premarket notification for a laser treatment system (Model: Hera, Armo) intended for hair removal and permanent hair reduction. It focuses heavily on comparing the technological characteristics of the new device to a predicate device (Laser Treatment System, Model: NYX and Grace, K210033) and outlines various performance data, primarily in the areas of biocompatibility, electrical safety, electromagnetic compatibility (EMC), and software verification and validation.

Crucially, the document explicitly states that "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." However, it does NOT contain any information about clinical performance studies or studies proving the device meets specific acceptance criteria related to its intended use (hair removal/reduction).

Therefore, I cannot provide the requested information regarding acceptance criteria for device performance based on the specific prompt's requirements, as those details are absent from the provided text. The document refers to "non-clinical testing" and does not detail any studies that would involve human subjects, expert review, ground truth establishment, or statistical analysis typical of device performance efficacy studies.

Thus, I can only state what is not present in the given text:

Based on the provided text, the following information regarding acceptance criteria and performance study details is NOT available:

1. A table of acceptance criteria and the reported device performance: The document lists technical specifications but no performance metrics for hair removal/reduction or acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
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 test set ground truth is discussed.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical laser treatment device.
7. The type of ground truth used: Not applicable, as no clinical performance data or ground truth related to hair reduction efficacy is presented.
8. The sample size for the training set: Not applicable, as no machine learning model or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through technical characteristics and non-clinical safety testing. The "Performance data" section (Section VII) details:

• Biocompatibility testing: Evaluated according to ISO 10993-1, meeting acceptance criteria for Cytotoxicity, Irritation, and Sensitization.
• Electrical safety and electromagnetic compatibility (EMC): Tested to comply with ANSI/AAMI ES60601-1, IEC 60601-1-2.
• Bench Testing: Tested to comply with IEC 60601-2-22 and IEC 60825-1 (laser safety).
• Software Verification and Validation Testing: Conducted and documented as recommended by FDA guidance.

These are all safety and engineering standards compliance rather than performance efficacy data for the device's intended clinical use. The "Conclusion" explicitly states: "The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device." This implies that clinical performance efficacy was not required for this 510(k) clearance, likely due to the substantial equivalence claim based on the predicate device's established performance profile.

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