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The Candela Family of Pulse Dye Laser Systems is indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.

The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 3, 7 or 10, 12 or 3x10 millimeters on the skin. The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The provided text is a 510(k) summary for the Candela Family of Pulsed Dye Lasers, dated June 13, 2005. It describes the device, its intended uses, and establishes substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any of the detailed metrics typically associated with proving device performance.

This document is a regulatory submission demonstrating substantial equivalence for a medical device (a laser system), not a clinical study report. Therefore, it does not include the type of information requested about acceptance criteria and device performance evaluation. The "Testing" section only mentions conformity to laser and electrical safety standards (CDRH Standard 21 CFR 1040 and UL/IEC 60601-1), which are regulatory compliance standards, not clinical performance acceptance criteria.

Based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on regulatory clearance through substantial equivalence, comparing the new device to existing predicate devices based on intended use, operating principles, and design aspects.

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