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Tattoo Removal

• dark ink: blue and black
• light ink: red
• light ink: sky blue
• light ink: green

Treatment of Vascular Lesions

• port wine birthmarks
• telangiectasias
• spider angioma
• cherry angioma
• spider nevi

Treatment of Pigmented Lesions

• cafe-au-lait birthmarks
• solar lentiginos
• senile lentiginos
• becker's nevi
• freckles
• nevus spilus
• nevus of ota

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Removal or lightening of unwanted hair with or without adjuvant preparation

Medlite C6 Q-Switched Nd:YAG Laser

The provided text is a 510(k) summary for the Medlite C6 Q-Switched Nd:YAG Laser. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". This means there are no acceptance criteria or studies presented within this document to demonstrate the device meets any specific performance metrics.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are reported.
2. Sample sized used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication method is described.
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: No such study is mentioned; this device is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: No ground truth is mentioned.
8. The sample size for the training set: Not applicable for this type of device.
9. How the ground truth for the training set was established: Not applicable for this type of device.

Conclusion:

The Medlite C6 Q-Switched Nd:YAG Laser received 510(k) clearance based on its substantial equivalence to predicate devices (Medlite™ IV, Medlite™ C3 Q-Switched Nd:YAG Lasers). The application explicitly states that no nonclinical or clinical performance data was submitted to demonstrate meeting specific acceptance criteria through a study. This implies that its safety and effectiveness were deemed acceptable based on the established performance and regulatory history of the equivalent predicate devices.

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