(78 days)
The Candela Vbeam Pulse Dye Laser is indicated for the following uses in:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, 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.
New indication : Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology.
Podiatry: Treatment of benign cutaneous lesion, such as warts.
The Vbeam is a 595 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor., to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology, for the treatment of wrinkles and the treatment of inflammatory acne vulgaris.. The Vbeam laser may be used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7 or 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.
The Candela Vbeam Pulse Dye Laser 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 document does not contain information about acceptance criteria or a study proving that a device meets such criteria.
Instead, the document is a 510(k) Summary for the Candela Vbeam Pulse Dye Laser System. This summary outlines the general information, description, testing performed, and a summary of substantial equivalence to predicate devices, along with the FDA's clearance letter and the device's indications for use.
Here's why the requested information is absent:
- Acceptance Criteria and Device Performance: The document states that the device "conforms to the Laser Performance Standard (21 CFR 1040)", "UL 2601 Electrical Safety Standard", and "Harmonized Standard EN 60601-1-2". These are general safety and performance standards for all lasers and electrical medical devices, not specific clinical acceptance criteria for the Vbeam's therapeutic outcomes (e.g., specific percentages of lesion clearance or reduction in wrinkles). The document does not provide specific numerical targets for device performance (e.g., "90% efficacy in reducing telangiectasia") nor does it present clinical study results to demonstrate achievement of such targets.
- Study Details: Since no specific clinical performance acceptance criteria are mentioned, there is no corresponding study described that proves the device meets them. The "Testing" section refers to compliance with regulatory standards, which are engineering and electrical safety tests, not clinical trials designed to quantify treatment efficacy in human patients against specific performance metrics.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: All these points relate to specific details of a clinical performance study. As no such study is presented in this 510(k) summary, these details are not available. The 510(k) process for this type of device often relies on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than requiring extensive new clinical efficacy studies for every clearance.
In summary, the document addresses regulatory clearance based on substantial equivalence to predicate devices and compliance with general safety standards, not specific clinical performance acceptance criteria or a study demonstrating achievement of such criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.