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The Schwartz Electro-Optics, Inc. CrystaLase 755 DP will be indicated for removal of tattoos of various types and colors, as well as epidermal, pigmented and vascular lesions. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated lasers. Schwartz Electro-Optics, Inc. seeks no new indications for the CrystaLase 755 DP laser system.

The Schwartz Electro-Optics, Inc. CrystaLase 755 DP System is a medical device which is capable of emitting a pulsed treatment laser beam at a wavelength of 755 nm under the guidance of a visible aiming beam. This laser may be used in a pulsed mode at various repetition rates.

The provided text is a 510(k) summary for the Schwartz Electro-Optics, Inc. CrystaLase 755 DP laser system. This document is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving performance against acceptance criteria for a novel device.

Therefore, the input does not contain the information requested to fill out the table and answer the questions about acceptance criteria and a study proving a device meets those criteria. The 510(k) process for this device relies on substantial equivalence to existing devices, not on new clinical performance data.

Specifically, the document states: "No new indications were sought in this premarket notification and no clinical data was presented." and "From a design and clinical perspective, the predicate and candidate laser devices are of the same technology and have the same intended use. Based upon an anlaysis of the overall performance characteristics for the devices, Schwartz Electro-Optics, Inc. believes that no significant differences exist."

Because no clinical data was presented, I cannot complete the requested information.

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