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The PicoLazer laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm
The 1064 nm wavelength of the PicoLazer laser system is indicated for:

• treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
• tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)

532 nm

• The 532 nm wavelength of the PicoLazer laser system is indicated for:
• treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
• tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III

The Rohrer Aesthetics, LLC PicoLazer™ laser system is a dual-wavelength (532 and 1064 nm) Nd:YAG laser system that offers a 450-picosecond pulse duration that produces a maximum energy of 500mJ at 1064nm and 250mJ at 532nm.

The PicoLazer laser system consists of a system console, an articulated arm, a laser handpiece, a footswitch, and a remote interlock plug. Other components necessary for operation, such as power cables, are also included.

This document is a 510(k) Summary for the PicoLazer Multi-wavelength Laser (K192583). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not primarily to prove clinical performance through a comparative effectiveness study with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for proving the device meets them, especially in the context of AI/human reader performance, is not applicable to this kind of FDA submission.

Here's a breakdown of the provided information in relation to your request:

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

• Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" are typically demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, or human reader improvement with AI) are not usually part of a substantial equivalence claim for a laser system cleared through the 510(k) pathway, especially when clinical studies are not required.

• Reported Device Performance: Instead of clinical performance metrics, the document reports on several performance tests related to safety and electromagnetic compatibility (EMC), which are the typical "performance data" for non-AI medical devices cleared through substantial equivalence. These are:

  • IEC 60601-1 Test for Medical Electrical equipment (General Requirements for basic safety and essential performance)
  • IEC 60601-1-2 Test for Medical Equipment (General Requirements for basic safety and essential performance: electromagnetic compatibility)
  • IEC 60601-2-22 Medical Electrical Equipment (Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser Equipment)
  • IEC 60825-1 Safety of laser products - Part 1 (Equipment classification, and requirements)

  The document states these tests were "performed in support of the substantial equivalence determination," implying they met the relevant standards, but it doesn't provide specific numerical results or pass/fail thresholds for these tests.

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

• Not Applicable. This submission is for a laser device, not an AI/Software as a Medical Device (SaMD) that typically uses test sets of diagnostic images. The performance data is based on compliance with electrical and laser safety standards, not a clinical test set of patient data.
• The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices."

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

• Not Applicable. No clinical test set requiring expert-established ground truth was used for this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was done, as this is a laser device that directly performs a treatment, not an AI system assisting human readers in diagnosis or interpretation. The document explicitly states "A human clinical study was not required".

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

• Not Applicable. This is not an AI algorithm; it's a physical laser system.

7. The type of ground truth used

• Not Applicable. For a device like this, "ground truth" typically refers to the device's technical specifications and adherence to safety standards, which are verified through engineering tests rather than clinical outcomes or expert consensus on medical images.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set.

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

• Not Applicable. This is not an AI/machine learning device.

Summary of Relevant Information from the Document:

The provided document demonstrates that the PicoLazer Laser System's clearance is based on substantial equivalence to existing predicate devices (PicoWay Laser System K170597 and PicoCare Family K181272).

• Key points for Substantial Equivalence:
  • Intended Use: The PicoLazer's intended use ("surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery") is compared and found similar to the predicate devices.
  • Indications for Use: Detailed comparisons of the specific indications for the 1064nm and 532nm wavelengths (e.g., treatment of benign pigmented lesions, tattoo removal for various ink colors and Fitzpatrick skin types) are provided and found to be substantially equivalent to the predicate devices.
  • Technological Characteristics: A direct comparison table is provided for technical specifications (Wavelength, Laser Type, Max Energy, Peak Power, Spot Size, Pulse Duration, Pulse Repetition rate) and physical specifications (Console Weight, Console Size, Voltage, Current, Frequency). While not identical, the applicant argues these differences do not raise new questions of safety or effectiveness.
  • Performance Data: Non-clinical performance testing (compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1) was conducted to ensure basic safety and essential performance, electromagnetic compatibility, and laser safety. No detailed numerical results from these tests are provided in this summary document, only that the tests were performed.
  • Clinical Studies: The document explicitly states: "A human clinical study was not required as the device is substantially equivalent to the predicate devices." This means the FDA did not require clinical evidence of efficacy or safety beyond the substantial equivalence argument and non-clinical testing.

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