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The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

The Catalys Precision Laser System ("Catalys System") is an ophthalmic surgical laser system indicated for use in cataract surgery to create a precise anterior capsulotomy and/or to effect lens fragmentation, thus facilitating efficient lens removal. The System also creates single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The System employs femtosecond ("FS") laser technology with integrated Optical Coherence Tomography ("OCT"), all of which are controlled and monitored by dedicated electronics. The System utilizes a common optical path for the OCT and femtosecond treatment laser (including the three-dimensional scanner and Liquid Optics 2[patient] Interface). As such, the beams are intrinsically co-registered and provide for precise overlap between imaging and treatment beams. Ocular surfaces recognized by the system software include anatomy within the anterior chamber, such as the anterior and posterior corneal surfaces and the anterior and posterior surfaces of the crystalline lens. Detailed axial or sagittal cross-sectional views are available via OCT, to demarcate proposed incisions versus adjacent ocular structures (for example, iris, pupil and limbus).

The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE or WHITESTAR SIGNATURE PRO Systems ("WHITESTAR SIGNATURE System(s)"). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

The Dual Pump Pack, Model OPO73 is a single-use phacoemulsification pack that is an optional accessory for use with the WHITESTAR SIGNATURE Phacoemulsification Systems (K151636, K111697 and K060366), which are used to facilitate the emulsification and removal of a cataractous lens. Similar to the predicate device, the Dual Pump Pack, Model OPO73 supports peristaltic and venturi aspiration by means of a tubing interface in combination with an over-molded rear cover consisting of a diaphragm (also called the gasket with fluid channels) and a rear cover designed to generate fluid outflow from a patient's eye through aspiration tubing lines.

The AMO WHITESTAR Signature Pro Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

The subject device is the AMO WHITESTAR SIGNATURE PRO Phacoemulsification System, which is an upgrade to the primary predicate device, the AMO WHITESTAR Signature Phacoemulsification System (K111697). Key device components included in this 510(k) submission are the system console, advanced linear (four-button) foot pedal (ALP), and wireless remote control. The system console and wireless remote control of the subject device are substantially equivalent to the console and wireless remote control of the primary predicate device in K111697. The Advanced Linear foot pedal (ALP) used with the subject device is substantially equivalent to the foot pedal used with the secondary predicate device, the COMPACT INTUITIV System, cleared under K133115. The subject device is classified under 21 CFR 886.4670 as a "phacofragmentation system," described as an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. Like the primary predicate device in K111697, the subject device is used to perform phacoemulsification by applying ultrasonic energy combined with the mechanical action of a vibrating phaco handpiece to the cataractous lens of the eye. The system performs four basic functions: phacofragmentation, irrigation of fluid, diathermy (bipolar), and vitrectomy.

The OP085 is used with the COMPACT INTUITIV System. The OP085 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

The Multiple-Use Pack, Model OPO85 is a reusable phacoemulsification pack that is an optional accessory for use with the COMPACT INTUITIV Phacoemulsification System (K133115), which is used to facilitate the emulsification and removal of a cataractous lens. The primary predicate device, the Single-Use Fluidics Pack, Model OPO80, is cleared for use with the COMPACT INTUITIV System and the secondary predicate device, the Sovereign Reusable Pack, Model OPO55, is cleared for use with the Sovereign Phacoemulsification System. Both the predicates share the same technology, intended use, and performance specifications as the subject device. The Multiple-Use Pack, Model OPO85, consists of a housing manifold, irrigation and aspiration tubing, irrigation inlet tubing connector, and a drain pump tubing connection. Like the secondary predicate device, Model OPO55, the OPO85 Pack is designed for reuse up to 19 times, for a total of 20 uses.

Either the DK7786 or DK7791 handpiece is used in combination with the ONE SERIES Ultra Cartridge, Model 1VIPR30 to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag. The Model DK7796 handpiece is used in combination with the Model 1MTEC30 cartridge to fold and assist in inserting AMO intraocular lenses that allow use of this injector in the approved IOL labeling, ONLY into the capsular bag.

The One Series ULTRA Cartridge, Model 1VIPR30, remains unchanged with respect to the predicate device that was cleared on October 2, 2008 under 510(k) K081545. The only modification to the 1VIPR30 device in comparison to the predicate device is with the coating material on the inside of the cartridge. The 1MTEC30 Cartridge is a smaller version of the 1VIPR30 and was assessed under a 510(k) Note-To-File. Both the 1VIPR30 and the 1MTEC30 Cartridges are used to fold and assist in the insertion of AMO Intraocular lenses that allow use of this 1VIPR30 and 1MTEC30 in the approved IOL labeling, ONLY into the capsular bag following cataract extraction: the tip of the cartridge has direct contact with the eye. They are both single-use devices composed of injection-molded polypropylene. The coating of the cleared 1VIPR30 Cartridge (predicate device) is biologically-derived material. The new coating will be made of synthetic materials that meets the same functional specifications of the predicate 1VIPR30 Cartridge.

The COMPACT INTUITIV System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIV System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

The COMPACT INTUITIV System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The system has the same surgical functionality and software features found in the primary predicate device, the SOVEREIGN Compact Phacoemulsification System (K111446) cleared on December 29, 2011. Like the predicate, the COMPACT INTUITIV is a mid-tier peristaltic system with a user-friendly interface that has updated technology and hardware to meet current electrical and material safety standards. The COMPACT INTUITIV consists of the System Console, the Wireless Remote Control, the Four-Button Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80

The Laminar Flow Phacoemulsification Tips are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments. The Irrigation Sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. The Phacoemulsification tip is intended for use in conjunction with the Irrigation Sleeve during ocular surgery.

Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to, and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract." The fragmentation needle, also referred to as a phaco tip, vibrates at an ultrasonic frequency and emulsifies the cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), is used to irrigate the eye and this is passed with the help of an Irrigation Sleeve. The Irrigation Sleeve directs the irrigation solution across the shaft of the phacoemulsification tip, allowing it to enter the eye during ocular surgery. This small molded component is placed over the Phacoemulsification tip. The proposed tips and irrigation sleeves are made of fitanium and medical grade silicone respectively. The subject of this 510(k) premarket notification is the Reusable Phacoemulsification Tips (Phaco Tips) & Irrigation Sleeves (Phaco Sleeves), which will be additions to the family of Disposable Laminar Flow Phacoemulsification Tips & Sleeves. The Phaco tips that are the subject of this 510(k) premarket notification have two different designs, straight and curved tip. The same two designs were the subject of the predicate device and have been cleared by the FDA under K111882 (AMO Laminar Flow Phaco Tips). These tips were cleared by the FDA for single use only and now AMO intends to introduce the reusable version of the same models into the market to offer a broad range of products to our customers. These tips will be compatible with all our currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device. Moreover, these 21G tips will also be compatible with our 21G Irrigation Sleeves (Phaco Sleeve), which is the other subject device of this 510(k) premarket notification. The 21G Irrigation Sleeve will have a slightly different design as compared to the predicate device, which has been cleared under K103023 (AMO Irrigation Sleeve). The reduced gauge size (21G) is designed for use with the 21G Phaco tips. The proposed Light Blue and Orange sleeve will be made of the same medical grade silicone material as the predicate device (Yellow Sleeve), with a difference in the colorant to distinguish between the various AMO sleeve offerings in the market.

The iFS Laser System is an ophthalmic surgical laser indicated for use: - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea - In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments - In lamellar keratoplasty and corneal harvesting - In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty - In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal

The iFS Laser System intended use is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser. The iFS Laser System uses focused femtosecond laser pulses to create incisions and separates tissues in the cornea. Corneal dissection with the iFS Laser is achieved through precise individual micro-photodisruptions of tissue, which are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce continuous incisions or tissue separation. These laser pulses are delivered through a disposable applanation lens that contacts the cornea while fixating the eye under low vacuum.

The Sovereign Compact Phacoemulsification 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.

The Sovereign Compact Phacoemulsification System) is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery for the disruption and extraction of a cataractous lens. As with other phacofragmentation systems, The System is identified in 21 CFR 886.4670 as a "phacofragmentation system that 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." The main performance functions of The System include ultrasonic phacoemulsification, diathermy, irrigation and aspiration, and vitrectomy. Ultrasonic phacoemulsification provides vibration at an ultrasonic frequency when used in conjunction with a compatible AMO ultrasonic handpiece. The System is controlled and powered by The System console, which includes an active color graphic user interface and receptacles for an automated IV pole, footpedal, remote control, and drainage packs.

The Laminar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.

Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract." The fragmentation needle - also referred to as a phaco tip - referenced in the aforementioned definition is the focus of this 510(k) premarket notification. Phaco tips vibrate at an ultrasonic frequency and emulsify a cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), used to irrigate the eye also passes through the hollow opening of the phaco tip. The subject of this 510(k) premarket notification is for the Phacoemulsification Tips (Phaco Tips) that are additions to the family of Laminar Flow Phacoemulsification Tips, of which there are two proposed designs: a straight tip and a curved tip. Both Phaco Tip models will be marketed as single-use devices, will be compatible with all currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device; the AMO Profinesse III Needle cleared under the AMO Profinesse III Handpiece 510(k), K951462.