Device Description. Invisalign aligners, developed by Align Technology, Inc. (“Align”) consist of a series of clear plastic, removable appliances that move your teeth in small increments. Invisalign’s product combines our 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 our doctors, a series of customised Invisalign aligners is produced specifically for your treatment.
Device Description. A device can consist of an IP Phone, desktop client, mobile client, analog device, and lobby or conference room device. For the Voice Centric, and Collaborate Seats, one desktop client is included as a standard feature. Mobile client is only supported with the Collaborate Seat and is limited to one mobile client per Collaborate Seat. A mobile device (e.g., phone, tablet, etc.) enabled with single number reach mobility licensing does not count toward the device maximums for each Seat. Additional Cisco licenses for the number of devices per user are not available as add-ons. Customer must purchase the appropriate Cisco HCS Seat to use more devices per user.
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. 4.2.1. Device description & features Besides a general description of the device, a more detailed description of the device attributes is necessary to explain how the device functions, the basic scientific concepts that form the fundamentals for the device, the component materials and accessories used in its principles of operation as well as packaging. A complete description of each functional component, material or ingredient of the device should be provided, with labelled pictorial representation of the device in the form of diagrams, photographs or drawings, as appropriate.
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. A complete description of all device types proposed for deployment, including all specifications and details required in Permit Requirement ES1.2.
Device Description. TableOfContents.doc
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. 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.
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.
