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The CoolSculpting Elite System is a skin cooling or heating device. It can be used in cooling or heating mode. Cooling Mode • Indicated for cold-assisted lipolysis (breakdown of fat) of the upper arm, bra fat, banana roll, thigh, abdomen, and flank (or "love handles") in individuals with a Body Mass Index (BMI) of 30 or less. • Intended for cold-assisted lipolysis of the submental and submandibular areas in individuals with a BMI up to 46.2. · Intended to affect the appearance of visible fat bulges in the upper arm, bra fat, banana roll, submental and submandibular areas, thigh, abdomen, and flank. · When used for cold-assisted lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area. - · Can be used to minimize pain and thermal injury during laser and dermatological treatments. - · Can be used as a local anesthetic for procedures that induce minor local discomfort. Heating or Cooling Mode - · Can be used to minimize pain post-trauma and post-surgery. - · Can be used to provide temporary relief of minor aches, pains, and muscle spasms. • The ZELTIQ Pretreatment Skin Wipe and gel pad facilitate thermal contact of the device with a patient's skin by mitigating minor variances in device-to-skin contact.

The CoolSculpting Elite System is a portable thermoelectric cooling device that applies controlled cooling to a treatment site. The CoolSculpting Elite System comprises of a control unit, detachable applicators, and accessories such as cycle cards, CoolAdhesive gelpads, gel traps, pretreatment skin wipes, liners, foam borders, and comfort straps. The device treats a target temperature down to -11°C with an accuracy of ±0.5°C. The device will automatically stop the treatment if the interface temperature goes past the target temperature by more than 1°C when treating below 5°C

NATRELLE INSPIRA® Single Use Sizers are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size breast implant.

NATRELLE INSPIRA® Single Use Sizers are designed for temporary intraoperative placement, to assist in determining the desired breast implant volume. They are used during breast augmentation or reconstruction procedures. NATRELLE INSPIRA® Single Use Sizers are constructed of a smooth silicone elastomer shell and are filled with responsive gel that contains the colorant cobalt aluminate blue spinel at a concentration of 0.1%. They have been designed to match the dimensions of the NATRELLE INSPIRA® breast implants. NATRELLE INSPIRA® Single Use Sizers are supplied sterile and are for single patient use, one sizer per breast.

The TrueTear Intranasal Tear Neurostimulator provides a tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.

The TrueTear device is a prescription only, non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. The device's technological principle is the application of low-level electrical stimulation to sensory neurons located in the nose to acutely increase tear production and improve dry eye symptoms. The device consists of three distinct non-sterile subassemblies - a base unit which controls and produces electrical stimulation waveform and enables the patient to control the neurostimulation, a disposable tip that is inserted into the nose and provides the contact surface for the stimulation to the target tissue located in the nose, and a charger case that protects the device and replenishes the sealed battery inside the base unit between uses.

REFRESH® RELIEVA™ FOR CONTACTS is indicated to lubricate and rewet soft and rigid gas permeable contact lenses, to help relieve dryness, discomfort and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to the application on the eye.

REFRESH® RELIEVA™ FOR CONTACTS is a sterile, buffered, isotonic, preserved solution. This aqueous formulation includes carboxymethylcellulose sodium, glycerin, boric acid, calcium chloride dihydrate, erythritol, magnesium chloride hexahydrate, potassium chloride, purified water, sodium borate decahydrate, sodium citrate dihydrate, sodium hyaluronate and the preservative PURITE® (stabilized oxychloro complex 0.01%). The solution may also contain hydrochloric acid and/or sodium hydroxide to adjust pH. All ingredients except for Purite are compendial grade (USP/NF/Ph Eur). The product is supplied in a teal colored, low density polyethylene (LDPE) multi-dose bottle and tip with a teal colored high impact polystyrene (HIPS) cap. The bottles are further packaged in paper cartons with a patient information insert.

The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133S Plus Tissue Expanders are designed to develop tissue flaps as part of two-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of a smooth surface expansion envelope, an orientation line, suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.

The TrueTear Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to increase tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base Unit, a reusable Charging Station, and a reusable Cover. The device design has not been significantly modified from the device granted under DEN160030, with technical changes including enabling Bluetooth functionality for one-way wireless communication, removal of material used in the disposable tip, disabling of the tip detection feature in the Base Unit, and addition of an optional mobile application (TrueTear App) for reading and summarizing device usage data.

The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

The XEN Glaucoma Treatment System consists of the XEN45 Gel Stent preloaded into the XEN Injector. The XEN45 Gel Stent is composed of a gelatin derived from porcine dermis, formed into a tube, and then cross-linked with glutaraldehyde. The inside diameter of the tube is approximately 45 um, its outside diameter is approximately 150 um, and it has a length of approximately 6 mm. The XEN45 Gel Stent creates a permanent channel through the sclera allowing aqueous flow from the anterior chamber to the subconjunctival space. The XEN45 Gel Stent is preloaded into an injector designed to place the XEN45 Gel Stent in the intended position. The injector with the preloaded implant is sterilized via gamma irradiation and is provided sterile. The injector is discarded after a one-time use.

The Natrelle® 133 Plus Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The Natrelle® 133 Plus Tissue Expanders are designed to develop tissue flaps as part of 2stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a BIOCELL® textured surface, an orientation line, three suture tabs (optional), a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs. The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

SERI™ Surgical Scaffold is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction.

SERI™ Surgical Scaffold is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra pure fibroin. The device is a mechanically strong and biocompatible bioprotein. SERI™ Surgical Scaffold is a sterile, single use only product and is supplied in a variety of sizes ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI™ Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction. SERITM Surgical Scaffold is designed to slowly bioresorb in parallel to neovascularization and native tissue ingrowth which results in eventual replacement of As bioresorption occurs, load bearing responsibility is SERI™ with native tissue. transferred to the new tissue ingrowth such that mechanical integrity is maintained at the site.