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The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) intended for use with the following:

HR Handpiece - Permanent hair reduction.

AR Handpiece - Treatment of inflammatory acne.

VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions.

SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions. Removal of unwanted hair.

The Clareon™ and Solarus™ Pulsed Light Systems are light-based medical device(s) which incorporate the use of the following accessory handpieces that are designed for specific treatments / uses: HR Handpiece - Permanent Hair reduction on all skin types; SR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions and removal of unwanted hair; VR Handpiece - Photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels(facial and leg veins), and treatment of benign pigmented lesions; AR Handpiece - Treatment of inflammatory Acne on skin types I-IV.

This 510(k) summary does not contain sufficient information to generate the requested tables and details about acceptance criteria and a study proving device performance. The provided text is a regulatory submission for the Clareon™ and Solarus™ Pulsed Light Systems, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance study results.

Here's why the requested information cannot be extracted from the input:

• No Acceptance Criteria or Reported Performance: The document explicitly states: "The differences in specifications of the Clareon™ and Solarus™ and the predicate device(s) do not result in different performances or raise new questions of safety or efficacy." This indicates that a direct performance study against specific acceptance criteria for the new devices (Clareon™ and Solarus™) was likely not conducted or reported in this summary. Instead, the argument for safety and effectiveness relies on the equivalence to previously cleared devices.
• No Study Details: Consequently, there are no details about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information because a specific performance study for these devices is not described.

Summary of what is available (and why it doesn't meet the request):

The document details the device trade names, common names, classification, legally marketed predicate devices, system description, and intended uses. The core of the submission is a "substantial equivalence" argument, meaning the devices are considered safe and effective because they are similar enough to devices already on the market that have been deemed safe and effective.

To answer your request, a document describing actual performance data, ideally from a clinical trial or bench testing, would be needed. This 510(k) summary states that no new performance data is needed because the new devices are considered equivalent to existing ones.

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