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The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. The purpose of this 510(k) is to increased the number of validated reprocessing cycles for the reusable handpiece and add the option of a wireless foot pedal.

The DolorClast® Radial is indicated for: - Relief of minor muscle aches and pains - Temporary increase in local blood circulation - Activation of connective tissue

The DolorClast® Radial is a portable radial pressure pulse device with an integrated air compressor. The DolorClast® Radial system is composed of the DolorClast® Radial console, handpiece, interchangeable applicator heads, and optional cart. Swiss DolorClast® Gel, previously approved under P050004, is also provided for coupling the treatment applicator to the patient's skin. The DolorClast® Radial console generates and controls the pressure pulse frequency and intensity. Air pressure from the console drives a projectile within the handpiece against the applicator head to generate the pressure pulses at the set frequency and intensity. Device activation is done by the practitioner via a trigger button on the handpiece. The applicator at the distal end of the handpiece transmits the radial pressure pulses to the targeted tissues via the coupling gel applied to the treated skin.

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy offers three modes of lithotripsy: 1) ultrasound alone; 2) shock wave alone; or 3) combined ultrasound and shock wave.. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a dual-energy reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a two-step foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Triloqy is an intracorporal lithotripter with three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

The Swiss LithoClast® Trilogy has three possible modes of operation: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The Swiss LithoClast Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

The Swiss LithoClast® Trilogy is a modified version of the Swiss LithoClast® Master, previously cleared under K012445. As with the predicate device, three possible modes of operation are available: 1) pneumatic lithotripsy alone; 2) ultrasound lithotripsy alone; and 3) and combined pneumatic and ultrasound lithotripsy. The LithoClast Trilogy system consists of the console used to set the treatment parameters and generate the treatment energy, a reusable handpiece, and a variety of probe sizes to enable use of the system with a wide range of commercially available endoscopes. Delivery of energy is controlled using a twostep foot pedal. Two models of the LithoClast Trilogy are available: one with a peristaltic pump and one with a pinch valve. Both versions can be used to suction stone fragments into the optional Stone Catcher. An external vacuum system is required to enable suction with the pinch valve model of the console.

The SWISS LITHOBREAKER is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

The EMS SWISS LITHOBREAKER is a handheld, standalone, battery operated intracorporeal lithotripter which uses a mechanical impact drive to fragment urinary tract calculi in the kidney, ureter, and bladder. The device generates around 3 impacts in continuous mode per second which are transmitted through the probes on the stones or a lower frequency by "single-pulse" mode, depending on the activation time of the button. The probes are introduced into the working channels of suitable endoscopes. The energy is sustained and stable throughout the life of the battery and the frequency drops only at the end of the battery life. An optional suction handpiece allows extraction of fragmented stones. The proposed device consists of the following: - Handpiece including powerpack . - LithoClast probes, non-sterile reusable and sterile single use . - LithoVac lv3 suction system with suction tubes . The SWISS LITHOBREAKER is also supplied with accessories for cleaning (endcap), periodic maintenance (O-rings), probe accessories (interface and probe guide), AAA batteries and sterile drapes.

The AIR-FLOW MASTER PIEZON combines the functions of an ultrasonic scaler and airpolishing unit within a single chassis. The AIR-FLOW MASTER PIEZON is intended for use in the following dental and periodontal applications: - Removing supra and subgingival calculus deposits and stains from teeth . - Periodontal pocket lavage with simultaneous ultrasonic tip movement . - Scaling and root planing . - Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha . - Plugging for amalgam condensation . - Amalgam burnishing . - Preparing, cleaning and irrigating root canals . - Cavity preparation . - Cementing inlays and onlays . - · Retrograde preparation of root canals The AIR-FLOW MASTER PIEZON is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. The AIR-FLOW MASTER PIEZON can be used for the following cleaning procedures: - plaque removal for placement of sealants . - surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers . - surface preparation prior to placing composite restorations . - effective plaque and stain removal for orthodontic patients . - cleaning prior to bonding ortho brackets . - cleaning implant fixture prior to loading . - · stain removal for shade determination - plaque removal prior to fluoride treatment . - plaque and stain removal prior to whitening procedure . The AIR-FLOW MASTER PIEZON is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIR-FLOW MASTER PIEZON is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIR-FLOW MASTER PIEZON is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of the base control unit, hoses and connectors for two handpieces, and a foot control containing a four-position switch. There are two mounts on the top of the base unit, one for an irrigation liquid container and the other for one of the two air-polishing chambers supplied with the device. The AIR-FLOW MASTER PIEZON is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures. The AIR-FLOW MASTER PIEZON is also supplied with the AIR-FLOW Handpiece and PERIO-FLOW Handpiece for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC (sodium bicarbonate), AIR-FLOW SOFT (glycine), and AIR-FLOW PERIO (glycine) prophylaxis powders. The AIR-FLOW MASTER PIEZON is supplied with accessories for attaching and removing instruments and nozzles from the handpieces and containers for storage and sterilization of the reusable components and accessories.

The miniMaster LED is an ultrasonic scaler that is intended for the following: - Removing supra and subgingival calculus deposits and stains from the teeth - Periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planning - Releasing crowns, bridges, inlays and posts as well as condensing gutta percha - Plugging for amalgam condensation - Amalgam burnishing - Preparing, cleaning, and irrigating root canals - Preparing approximal cavities - Cementing inlays and onlays - Retrograde preparation of root canals

The miniMaster LED is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece. The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.