Search Results

IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm2 (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line). The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The Medical Electronic Thermometer (FC0). FC02) is intended to measure the human body temperature under the arm. The devices are reusable for clinical or home use for people of all ages.

The Medical Electronic Thermometer (FC01, FC02) is a hand-held device which can measure human body temperature at the site of the armpit. The devices are reusable for clinical or home use for people of all ages. The results can be displayed on the LCD. The FC01 and FC02 have only one operating mode which is direct mode. The Medical Electronic Thermometer measures human body temperature by placing the probe tip under the armpit with a measuring time of about 300 seconds. The Medical Electronic Thermometer consists of a temperature sensor (NTC), low power integrated circuit (IC), buzzer, and battery. The resistance of sensor changes with temperature and the integrated circuit (IC) converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD.

The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.

The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.

The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.

The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.

The Natural Line abutment is indicated for use in cases where the placement of the implant requires an angled reconstruction for an esthetic result. The abutment can be used to restore crowns for single tooth replacement and bridges for bound situations

Not Found

HIP: Hip capsule repair, Acetabular labrum reattachment SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis

The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.

InstaFix™ Shape Memory Fixation System is intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament InstaFix™ Shape Memory Fixation System is also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs

InstaFix™ Shape Memory Fixation System is a set of dynamic compression implants made from shape memory metal nickel-titanium alloy called NiTinol. The staples are available in sizes 8mm to 30mm. The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. InstaFix™ Shape Memory Fixation implants are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process. Each staple is packaged sterile along with the corresponding drill guide and implant holder. The one time use Accessory Kit and the Sizer Kit are packaged sterile to assist in the procedure. The Accessory Kit contains one drill and two locating pins. The Sizer Kit contains samples of the available staple sizes.

The CinchLock Knotless Suture Anchor and the NanoTack Suture Anchor 1.4mm are intended for the fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee. Please see individual indications for use statements. The NanoTack® Suture Anchor, previously cleared under 510(k) K110473 and K130351, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis. The CinchLock™ Knotless Anchor, previously cleared under 510(k) K123651, is intended for fixation of soft tissue to bone in the hip, shoulder, foot/ankle, hand/wrist, elbow, and knee, in the following procedures: Hip capsule repair, Acetabular labrum reattachment, Capsular stabilization, Bankart repair, Anterior shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis, Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Extra-capsular repairs, Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquous advancement, Iliotibial band tenodesis.

The Pivot Suture Anchors which are part of this expanded indications submission are as follows: Pivot CinchLock Knotless Suture Anchor, Pivot NanoTack Suture Anchor 1.4mm. These anchors are non-degradable suture anchors manufactured from PEEK-OPTIMA® LT1 polymer. The CinchLock and NanoTack Anchors are attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the CinchLock Knotless Suture Anchor and Inserter. The Pivot NanoTack Suture Anchor incorporates a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture. The CinchLock Knotless Suture Anchor and NanoTack Suture Anchor 1.4mm devices are provided as a single use sterile devices.

The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.

The Pivot Knotless Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.

The Pivot Knotless Suture Anchor is a non-degradable suture anchor manufactured from PEEK-OPTIMA® LT1 polymer attached to / pre-assembled to a stainless steel Inserter. Non-degradable ultra-high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture is provided in the sterile package with the Knotless Suture Anchor and Inserter. The Knotless Suture Anchor with Inserter and Suture is provided as a single use sterile device.