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An intense pulsed light, the Powerlite 600® EX System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoaqulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

• The treatment of tattoos; .
• The treatment of benign pigmented epidermal lesions including dyschromia, . hyperpigmentation, melasma, ephelides (freckles);
• The treatment of cutaneous lesions including warts, scars and striae; .
• The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema or rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• The removal of unwanted hair from all skin types, and to effect stable long-term, . or permanent, hair reduction in skin types I-V.

The Powerlite 600® EX System delivers pulsed light at a wavelength beginning at a wavelength of 515nm. The device consists of three interconnected sections: a light system console (including software and control electronics), a control and display panel; and one or more attached hand-piece(s).

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. In fact, it explicitly states:

• Discussion of Clinical Tests Performed: 8. Non-Applicable

This indicates that no clinical testing was performed or submitted as part of this 510(k) premarket notification. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than performance against specific acceptance criteria derived from a clinical study.

Therefore, I cannot provide the requested information.

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The Powerlite 600® EP System is used for the removal of unwanted hair.

The Powerlite 600® EP System delivers pulsed light at a wavelength beginning at a wavelength of 600nm. The device consists of three interconnected sections: the system console which houses the internal cooling system, power supply and micro-controller, the handle hose to the handpiece, and the handpiece, which houses the wavequide.

The provided text is a 510(k) summary for the Powerlite 600® EP System. It does not contain details about acceptance criteria, device performance, clinical studies showing the device meets acceptance criteria, or ground truth establishment.

The document explicitly states:

• "8. Discussion of Clinical Tests Performed: Non-Applicable"

This indicates that the submission did not rely on clinical trials to demonstrate substantial equivalence. Instead, it focused on the device's technical similarity and intended use compared to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from the provided text. The document's purpose is to establish substantial equivalence based on non-clinical aspects and comparison to a predicate device, not to report on clinical performance against specific acceptance criteria.

Ask a specific question about this device