Search Results

The PhotoGenica 532 Laser system is indicated for the treatment of vascular and pigmented lesions of the skin.

The PhotoGenica 532 laser is indicated for the treatment of benign cutaneous vascular and pigmented lesions.

The PhotoGenica 532 Laser is a CW, frequency-doubled Nd:YAG laser system with a wavelength at 532 nm. The treatment beam output for the PhotoGenica 532 is 4 watts CW at 532 nm. The aiming beam is provided by 5 mW, 670 nm diode laser. Exposure times for the PhotoGenica 532 (in seconds) are 0.02, 0.05, 0.1, 0.25, 0.5, 1.0 and continuous. Laser activation is by a footswitch. Overall weight of the unit is 25 lb (11 kg). Electrical power requirement is 120/230 VAC ±10%, 5/3 Amps, 50-60 Hz. The system is air-cooled by fans. Accessories available for use with the PhotoGenica 532 include 0.2, 0.5, 0.7, 1.0 and 1.5 mm (spot diameter) handpieces.

The provided 510(k) summary for the Cynosure PhotoGenica 532 Laser does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

This 510(k) submission is a "premarket notification" for substantial equivalence. The device is being compared to a predicate device (American Medical Laser Nuvo-Lase 660 Laser) based on its technical characteristics (wavelength, power, pulse duration) and intended use. The focus of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed device, rather than proving its performance against specific quantitative acceptance criteria through a clinical study.

Here's a breakdown of why the requested information is not present based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not provided. The submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or associated data is described, as no clinical or nonclinical performance data was submitted.

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 test set or expert ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set or adjudication process is mentioned.

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 laser system, not an AI-assisted diagnostic tool, and no MRMC study or AI integration is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for performance evaluation.

8. The sample size for the training set: Not applicable, as this is a physical medical device and not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as this is a physical medical device and not a machine learning algorithm.

In summary, the 510(k) for the Cynosure PhotoGenica 532 Laser is based on demonstrating substantial equivalence to a predicate device through a comparison of technical specifications and intended use, rather than through clinical performance studies against specific acceptance criteria.

Ask a specific question about this device