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The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs). The Multi4 System consists of the following components: • Multi4 Pump (with Integrated Fluid Control) o Footswitch • Multi4 B o Resectoscope & Needle o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments: - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators: - DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL) - LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA) - VASCULAZE 1064 (previously cleared as Vasculaze) - FORMA (previously cleared as Forma (Plus)) - PLUS (previously cleared as Plus/Plus) - MORPHEUS8 - MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

The HybridAPC probe is intended for the submucosal injection of sterile normal saline to lift mucosa using direct visualization through an endoscope and for HF ablation of the mucosa, with or without lesions, by Argon Plasma Coagulation (APC). Indications include but are not limited to: - Barrett's esophagus - Ulcers - Arteriovenous Malformations - Angioma - Angiodysplasia - Gastric Antral Vascular Ectasia (GAVE) - Radiation Proctitis - Gastroesophageal reflux disease (GERD) - Post-polypectomy ablation/Post-EMR ablation

The HybridAPC probe is a flexible, sterile, single use monopolar probe that combines the technologies of hydrosurgery and argon plasma coagulation (APC) in one instrument. Each function can be activated independently without the need to change instruments. It is used with the hydrosurgical unit Model ERBEJET® 2 and an Erbe APC unit in combination with an electrosurgical unit (ESU) VIO Model. The probe is used with endoscopes with a working channel diameter larger than 2.5mm. The hydrosurgical function is intended to deliver a pressurized fluid to create a fluid cushion beneath the mucosa/mucosal lesion to be ablated which serves as a mechanical and thermal protection layer for the underlying tissue and to reduce the risk of perforations. The electrosurgical (i.e. APC) function is intended for ablation of the lifted mucosa/mucosal lesion. The Hybrid APC probe has a length of 1.9 meters and an outer diameter (OD) of 2.3mm. The HybridAPC probe is connected to the units via respective cables/tubings. The settings or adjustment of application parameters is performed via the units. Activation of the instrument is done using a footswitch.

Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient. Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.

The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece. The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin. The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis. The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite

ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emitted onto patient skin. The device consists of a console and seven handpieces that emit either ablative or non-ablative radiofrequency.

DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.

DELPHI System is a bipolar, high radiofrequency electrosurgical device designed for coagulation and ablation of tissue and hemostasis during arthroscopic surgery. DELPHI system consists of DELPHI II (Generator), power cable, Mode Footswitch, output Footswitch, DELPHI PLUS (Electrodes) and DISCORE (Electrode). The DELPHI II is an electrically isolated radiofrequency generator designed to deliver power for soft tissue ablation (vaporization) and coagulation procedures in arthroscopic surgery. The DELPHI II offers the operator the flexibility to choose from a range of functional modes using the front panel set-up options. These modes include PETTIE MODE and GRANDE MODE for tissue ablation and coagulation. DELPHI PLUS and DISCORE bipolar electrode is a foot-controlled sterile, single-use electrosurgical electrode intended to deliver radiofrequency energy for coagulation and ablation of tissue and hemostasis during arthroscopic surgery in conjunction with DELPHI System.

EMS is used for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable. EVE Synergy has Synergy mode and Pro mode. Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃. Pro mode has low frequency function that uses the Pro handpiece with tip. It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.

The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation. The gi2000 consists of the high-frequency electrosurgical unit with control panel and an operating foot switch. The handpiece (electrodes) and dispersive pad (return electrode) are not included with the gi2000. Instead, device labeling lists optional pieces that have been validated with the device.

The Vasoview Hemopro 3 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall. The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System.

The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current only; it does not utilize radiofrequency energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and should, therefore, be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro 3 Power Supply.

The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is composed of the NEUROMARK Device and the NEUROMARK Radiofrequency (RF) Console. The NEUROMARK Device is a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bioimpedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK Device is intended for single use and provided sterile (EO). The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the Device. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.