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ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: - . A connector to connect to the console - A cord where electrical cables and hydraulic tubes pass in - A plastic shell - . A Laser cavity - . A mechanical shutter - . An optical guide - . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm) The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

The provided FDA 510(k) summary for the ERISE Laser Handpiece does not contain information about acceptance criteria for a device performance study or any study proving such criteria are met.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Quanta System 2940 nm Er:YAG laser handpiece) based on technological characteristics and non-clinical performance data.

Here's a breakdown of why the requested information cannot be provided from this document:

1. No Clinical Performance Data: The document explicitly states under "Clinical Performance Data:" "None". This means no studies were conducted to evaluate the device's clinical effectiveness in terms of specific outcomes or meeting pre-defined acceptance criteria for efficacy.

2. Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological features, safety standards, and non-clinical performance, rather than conducting new clinical trials with acceptance criteria.

3. Non-Clinical Data for Safety and Compatibility: The "Non-Clinical Performance Data" section describes tests related to:

   • Safety and electromagnetic compatibility (EMC): Compliance with standards like IEC 60601-2-22, IEC 60825-1 (for safety) and IEC 60601-1-2 (for EMC) for the DEKA LUXEA platform (which the ERISE handpiece connects to). These are regulatory compliance tests, not performance studies with acceptance criteria for specific clinical outcomes.
   • Software Verification and Validation: This ensures the software of the DEKA LUXEA platform (with the ERISE handpiece) functions as intended. Again, this is a form of regulatory compliance and quality assurance, not a performance study evaluating clinical efficacy.

Therefore, it is not possible to complete the requested table or answer the specific questions about acceptance criteria and performance studies because such information is not present in this 510(k) submission. The device's approval is based on its similarity to an already cleared device and adherence to relevant safety and software standards, not on new clinical performance data demonstrating specific efficacy outcomes against predefined acceptance criteria.

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