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The ProLite III TM Pulsed Light System with the HR handpiece (containing a 630-1100 nm, 630-990 nm, or 750 - 1100 nm filter) is intended for the removal of unwanted hair in all Fitzpatrick skin types.

The ProLite III TM Pulsed Light System with the PR handpiece (containing a 530-1100 nm, 550-1100 nm, or 580-1100 nm filter) is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions.

The ProLite III IPL is a device designed for dermatological use. It produces an intense light pulse within the wavelengths of 450 to 2000 nanometers, which is tailored to specific indications by a bandpass filter. The system is composed of a Tower which encloses the power supply and cooling system and a Handpiece which contains the flash lamp, filter and waveguide. The device is controlled by a touchscreen graphic user interface.

This 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological similarities and equivalent physical output characteristics.

Therefore, I cannot populate the requested tables and information based on the provided text.

Here's a breakdown of why the requested information is absent from this document:

• No Performance Data for Acceptance Criteria: The document describes the device's technical specifications (e.g., wavelength range, fluence, pulse duration) and its intended uses. However, it does not specify quantitative performance metrics (like efficacy rates, accuracy, precision, or safety outcomes) that would serve as acceptance criteria for a new clinical or performance study.
• No Study Details: The submission relies on "substantial equivalence" to previously cleared predicate devices (ProLite K021304 and Dermalux K010618) rather than presenting new clinical or performance study data for the ProLite III. The core argument is that because the new device uses similar technology and has equivalent output characteristics, its risks and benefits are comparable to those already established for the predicates.
• No Mention of Training or Test Sets: Since no new performance study is detailed, there's no discussion of sample sizes for test sets, training sets, data provenance, ground truth establishment methods, or expert involvement.
• No MRMC or Standalone Study: The document does not describe either a multi-reader multi-case comparative effectiveness study or a standalone algorithm performance study. These types of studies are typically conducted for AI/software devices or when demonstrating new performance claims that go beyond established equivalence.

In summary, the provided 510(k) summary is a "traditional" 510(k) submission that leverages substantial equivalence to predicate devices, rather than a submission that presents novel performance data against specific acceptance criteria.

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