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The Cynosure Apogee-TKS laser is indicated for vascular lesion removal and stable, long-term, or permanent hair reduction.

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area.

The Apogee-TKS Laser consists of three interconnected sections: the power supply, the water cooling and heating system and the optical bench. The device is capable of delivering 60 J/cm² at 5, 10, 20 or 40 milliseconds pulse width.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary and an FDA clearance letter for the Cynosure Apogee-TKS Laser, indicating its substantial equivalence to a predicate device.

Key Findings from the Documents:

• No Clinical Performance Data: The 510(k) summary explicitly states "Clinical Performance Data: None" and "Non-clinical Performance Data: None."
• Substantial Equivalence: The FDA clearance is based on the device being "substantially equivalent" to the Cynosure Apogee Laser in terms of "treatment wavelength, pulse duration, pulse energy and biological effects." This implies that the device is deemed safe and effective because its characteristics are similar to an already cleared device, not necessarily through a new study demonstrating pre-defined acceptance criteria for the new device itself.
• Intended Use/Indication for Use: The device is indicated for "stable, long-term, or permanent hair reduction." Permanent hair reduction is further defined as "long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area." This is the definition of the desired outcome, but not a quantifiable acceptance criterion with a specific threshold that the new device had to meet through a study.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance via substantial equivalence rather than a detailed performance study with acceptance criteria.

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