Device Description. Invisalign aligners, developed by Align Technology, Inc (“Align”) consist of a series of clear plastic, removeable appliances that move your teeth in small increments. Invisalign’s product combines your doctor’s diagnosis and prescription with sophisticated computer graphics technology to develop a treatment plan which specifies the desired movements of your teeth during the course of your treatment. Upon approval of a treatment plan developed by your doctor, a series of customized Invisalign aligners is produced specifically for your treatment.
Device Description. 4.2.1. Device description & features
Device Description. MediMatch Aligners, developed by MediMatch Dental Laboratory consist of a series of clear plastic, removable appliances that move your teeth in small increments. MediMatch’s product combines your doctor’s diagnosis and prescription with sophisticated computer graphics technology to develop a treatment plan which specifies the desired movements of your teeth during the course of your treatment. Upon approval of a treatment plan developed by your doctor, a series of customized MediMatch Aligners is produced specifically for your treatment.
Device Description. The NuBrace System, developed by Xxxxxxx Hills Dental Corp , consists of a series of clear polymer, removable appliances (aligners) that move your teeth in small increments from their original state to a more ideal treated state. Some patients may also require bonded aesthetic attachments (small, tooth-colored dental composites) and/or elastics on their teeth to facilitate specific dental movements. The NuBrace System combines your doctor's diagnosis and treatment plan with sophisticated computer graphics technology to develop your series of customized aligners. You typically wear the aligners in pairs, one on your upper dental arch and one on your lower dental arch. Each aligner fully covers your teeth and is virtually invisible when in place; You wear each pair of aligners as instructed by your doctor.
Device Description. Invisalign® clear aligners consist of a series of clear plastic, removable appliances that move your teeth in small increments. Clear Aligner (Invisalign®) orthodontic treatment combines your doctor’s diagnosis and prescription with sophisticated computer graphics technology to develop a treatment plan which specifies the desired movements of your teeth during the course of your treatment. Upon approval of a treatment plan developed by your doctor, a series of customized Invisalign aligners is produced specifically for your treatment.
Device Description.
2.1 Device Overview The Active Needle Endoscopic Treatment (ANET) Applicator is a disposable bipolar electrosurgical applicator used for the coagulation and necrosis of soft tissue. Each Applicator consists of a 19 gauge needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator works with ancillary equipment which include an ultrasound endoscope and a compatible electrosurgical generator. The ANET Applicator has been shown to be compatible with the previously cleared/approved Olympus ESG- 100 or Olympus ESG – 300 Electrosurgical Generator. Other radiofrequency generators will be added as compatibility is established. A standard infusion pump can be used to infuse small quantities of saline during active ablation. Saline is administered to cool the electrodes during ablation, and to prevent the tissue surrounding the target tissue from dehydration. To perform ablation, the flexible portion of ANET device is first inserted into an ultrasound endoscope with a working channel of 2.2mm or greater, then locked onto the adapter biopsy valve on the endoscope using the endoscope adapter on the handle. The handle facilitates advancement of the sheath and needle/proximal electrode during puncture of the target tissue. Once the needle is positioned in place, the handle is used to facilitate advancement and of the coil. The coil in the target tissue and helps to hold the device in place during treatment. To perform ablation, the bipolar plug on the ANET Applicator is connected to the compatible electrosurgical generator. The generator is set to the appropriate power level included in the Instructions for Use (IFU). During ablation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. Once the target energy has been reached, ablation is stopped, and the electrodes are retracted from the target. Additional ablations can be performed to achieve a larger coagulation zone.
Device Description. The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.
Device Description. The Anoto pen positioning system determines absolute positions of the Anoto pen tip by reading and decoding information encoded in a proprietary pattern printed on the paper surface. The Pen Positioning System (FLY PPS) consists of the following modules: • The [*]. • A [*], which consists of • An [*] • A [*] • A [*] • [*] software • [*] software for Anoto [*].
Device Description. The RevLite Q-Switched Nd:YAG is cleared under FDA K083899 for Tattoo Removal. The PICOSURE laser has been cleared by the FDA under 510 (k) K121346 for the removal of tattoos and benign pigmented lesions. It is believed that these shorter pulses may be more efficient in disrupting pigment and possibly resulting in better treatment outcomes. The sponsor deems this device a non significant risk. The system was tested to ensure compliance with federal laser performance standards, 21CRF Part 1040. See section 11 for full specifications.
Device Description. 5.1. The device is a catheter comprised of an injection lumen and a sheath lumen. The injection lumen should allow for the solution to be delivered with a reasonably low number of adverse events, within a reasonable rate in accordance with user feedback and with an acceptable level of retention and functionality. The sheath lumen allows flushing of the space between the core needle and the deflectable sheath to enhance needle movement.
5.2. The distal end of the device system should be atraumatic and facilitate ease of entry/tracking to the appropriate location in the heart. The distal needle tip should not buckle under standard insertion techniques.
5.3. The proximal end of the catheter should include sufficient standard connectors to allow the physician to connect to, monitor, flush and inject through. Standard syringe compatibility allows for manual incremental injections and flexibility for various solution delivery volumes. Product Specification Rev.:10 TITLE: SR200 MyoCathTM PEMI Device Cover Page
5.4. The device is anatomically curved, or allowed to curve, to allow for proper placement(s) into the left ventricle. Positioning of the device will be predictable and stable once in place.
5.5. The environment in which the SR200 MyoCath™ is to be used will be a cardiology suite. The product will interface with cardiology equipment, instruments and devices.
5.6. This device is for single use only.
