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The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.

The Spectrapulse® pulsed light system is intended for long term hair removal on skin types I-V according to the Fitzpatrick scale.

The SpectraPulse system is a light-based medical device designed for long term hair removal on skin types I-V

This 510(k) submission for the SpectraPulse® pulsed light device by Primary Technology does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary of safety and effectiveness, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

"The differences in specifications of the Spectrapulse® and the predicate device(s) do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the SpectraPulse system is substantially equivalent to the legally-marketed predicate device(s)."

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from the provided text. The document does not describe the specific performance characteristics of the SpectraPulse device or list any clinical or technical study data to support its performance beyond the claim of substantial equivalence.

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The SpectraPulse system is indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (facial and leg veins), benign pigmented lesions in skin types I-IV according to the Fitzpatrick scale.

The Spectrapulse® pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale.

The SpectraPulse system is a light-based medical device designed for treatment of vascular lesions (fascial and leg) and benign pigmented lesions.

The provided text does not contain information about specific acceptance criteria, study details proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies.

Instead, the document is a 510(k) summary for the SpectraPulse® pulsed light device. Its primary purpose is to establish substantial equivalence to a legally marketed predicate device (Palomar Medical Technologies, Inc. EsteLux TM, K020453) rather than to present detailed performance study data against pre-defined acceptance criteria.

The "Performance Data" section in the summary is conspicuously empty, followed by a "Conclusion" that states: "The differences in specifications of the Spectrapulse® and the predicate device do not result in different performance or raise new questions of safety or efficacy. Based on the foregoing, the SpectraPulse system is substantially equivalent to the legally-marketed predicate device."

Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text.

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