(218 days)
Provide illumination at surgical site.
Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.
I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for a medical device (Fiber Optic Phacofragmentation System) and focuses on describing the device, its intended use, and its equivalence to predicate devices, rather than presenting acceptance criteria and study results.
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1301 - 20th Street #260 Santa Monica, California 90404 (310) 453-0551
OCT - 2 1996
960811
510(k) Summary per section 807.92(c)
Submitters Name: Michael Reynard, M.D. Address: 1301 - 20th Street #260, Santa Monica, CA 90404 FAX: 310-315-0133 Telephone: 310-453-0551 Contact Person: Michael Reynard, M.D. Date of Summary: 02/12/1996
Name of Device: Fiber Optic Phacofragmentation System
Tradename of Device: Phacoscopers
Equivalence: The subject device combines predicate phacofragmentation system and fiber optic light guides for transmitting visible light.
Description of Device: Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.
Intended Use of Device: Provide illumination at surgical site.
Comparison with predicate devices: Medical grade fiber optic guides consistent with Class II classification devices used for intraocular illumination (Classification number 876-1500; Product Code 78FCW) are combined with a phacofragmentation handpiece. Electrical power and light sources for the fiber optic phacofragmentation handpiece (Class II; Classification number 886.4670; Product Code 86HQC) are identical with those currently used. Construction materials are identical with phacofragmentation handpieces and fiber optic devices that are legally marketed devices currently in use. Colors are identical to those in legally marketed devices currently in use.
Sterilization Method: 1) Autoclave for fiber optic phacofragmentation handpiece incorporating quartz fiber optics, or 2) sterilizers customarily used for fiber optic instruments incorporating quartz or plastic fiber optics.
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§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.