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The Diode Laser Therapy Systems is intended for use in dermatological procedures requiring coagulation.

Indications for Use:

Mixed Wavelength Handpiece (755 nm + 808 nm + 1064 nm):

• Temporary hair reduction (Hair-Removal function).
• Treatment of benign vascular and vascular-dependent lesions (Vascular-Lesion function).

Single Wavelength Handpieces (755 nm, 808 nm, or 1064 nm):

• Hair removal and permanent hair reduction in all skin types (Fitzpatrick skin types I-VI).

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of a treatment regimen.

The Diode Laser Therapy Systems, Model WLA-02, is a medical device intended for dermatological procedures requiring coagulation. It includes mixed and single wavelength handpieces designed for temporary and permanent hair reduction, as well as the treatment of benign vascular lesions. The system delivers controlled laser energy to target melanin or vascular structures while integrated cooling helps protect surrounding skin tissue. The system comprises:

• Main Console: Includes power switch, handpiece holder, LCD touch screen, emergency shut-off, hand-grip grab bar, handpiece connector, access door, observation window, power input, inlet, air switch, gate interlock connector, foot switch connector, vent, drain, and cooling fans.
• Treatment Handpiece: Incorporates laser aperture, laser emission indicator, laser emission system, and handpiece display screen.
• Foot Switch: Activates laser emission.
• Embedded Software: Diode Laser Therapy Systems Control Software.

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The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) is intended to provide neuromuscular electrical stimulation for the rehabilitation and re-education of weak pelvic floor muscles in adult women. It is indicated for the treatment of stress, urge, and mixed urinary incontinence and to help maintain urinary continence.

The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) is a non-implantable, home use pelvic floor muscle stimulator designed to provide electrical stimulation to the pelvic floor muscles for treatment of stress, urge, and mixed urinary incontinence.

The device contains the electrical stimulator unit, a vaginal probe, a carrying case, 2 lead wires, and a user manual. The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) has four modes. The treatment modes are designed to treat stress, urge, mixed urinary incontinence, and tone mode by providing targeted stimulation to the pelvic muscles with varying pulse widths, frequencies, ramp-up and ramp-down times, and hold-on and hold-off times. The device is powered by a rechargeable Li-ion battery and controlled by a button interface with adjustable intensity levels. An LCD display shows the current program and intensity level.

The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) includes one reusable (single-patient use), dual electrode vaginal probe electrode (Model: SA-3478) packaged together with the main device.

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The SANDRO Dual Laser System is indicated for the following at the specified wavelength:

755nm

• Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is 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. On all skin types (Fitzpatrick I - VI) including tanned skin.
• Treatment of benign pigmented lesions.
• Treatment of wrinkles.
• The photocoagulation of dermatological vascular lesions (such as pant-wine stains, hemangiomas, telangiectasias)

1064nm

• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. Permanent hair reduction is 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
• The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Treatment of wrinkles.

1064nm

• Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

The SANDRO Dual laser system consists of laser resonator, touch screen monitor, optical fiber with handpiece, and foot switch.

1. Nd:YAG Laser
   A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Nd:YAG, resulting in the laser energy source. The laser energy generated by the medium of Nd:YAG is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue.

2. Alexandrite Laser
   A certain amount of electric power set by the LCD monitor is permitted to the laser resonator through the power supply. Then, the laser resonator delivers the electrical energy to the flash lamp which converts the electrical energy into the light source. This concentrated light source is radiated on the medium of Alexandrite, resulting in the ultimate laser energy source. The laser energy generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for a variety of medical purpose such as an ablation, incision and removal of targeted tissue.

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The PUREVUE™ FMS is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

The PUREVUE™ FMS is an arthroscopy pump with irrigation and suction function. The device is equipped with two independent peristaltic pump systems and can be used both as an irrigation pump and as a suction pump. This provides two options for operating the unit: the Single roller mode and the Dual roller mode.

Single roller mode (Inflow): In this mode, the Inflow Cassette Tube transmits fluid from saline bags to the inflow cannula or sheath at the surgical site.

Dual roller mode (Inflow/Outflow): This mode uses both the inflow and outflow functions of the pump via the Inflow Cassette Tube and Outflow Cassette Tube.

The device is non-invasive and designed to be placed in non-sterile areas.

The PUREVUE™ FMS is a fluid management system based on the peristaltic principle that provides irrigation and suction functionalities for arthroscopic procedures. Along with its accessories (Tube set for irrigation (single-use), Tube set for suction (2-lines, single-use), Day use tube set for irrigation (pump part, 10 applications), Patient tube for irrigation (single-use), Tube set for suction (1-line, single-use), Tube set inflow 4-spike adaptor, Tube set for vacuum incl. filter (30-day use, reusable), autoclavable remote control and double foot switch), the device delivers medical sterile irrigation fluid from fluid bags to the cavity. This distends the cavity to create space for the procedure. In addition, the device along with its accessories can aspirate fluid from the patient's cavity to improve the visibility.

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Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older.

Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

Withings BeamO, model name SCT02, is a multi-function handheld battery powered device with ECG, stethoscope, temperature capabilities. Withings BeamO can record a 1-lead ECG using two stainless steel electrodes. It analyzes the data collected by the integrated two stainless steel electrodes to generate an one-lead ECG waveform and provides the ECG recording to the user for a given 30 second measurement.

Withings BeamO is also a contactless thermometer that can measure body temperature in adjusted mode.

Withings BeamO is also a digital stethoscope that can be used to auscultate heart and lung sounds. The sensor generates an electric charge when subjected to mechanical vibrations. The charge variations are amplified and digitized by an audio codec. Sound filters are applied to the resulting sound wave in order to listen to the patient's heart and lung sounds with clarity.

Withings BeamO consists of hardware and embedded software. Withings BeamO works in conjunction with a companion software on the Withings App. Withings BeamO communicates with the companion software via Bluetooth Low Energy (BLE). The device measurement results and recordings are synchronized with the companion software using Wi-Fi/Cellular data via the Withings servers.

Withings BeamO does not include ECG analysis or ECG-derived heart rate functionalities.

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The Lunderquist Extra Stiff Wire Guides are intended to facilitate catheterization and/or placement of devices during vascular interventional procedures.

The Lunderquist Extra Stiff Wire Guides are intended for use in the aorta, including its access vessels and major adjacent vessels.

The Lunderquist Extra Stiff Wire Guides are auxiliary devices and hence not primary interventional devices themselves. Instead, they are intended to facilitate vascular access and/or delivery of over-the-wire medical devices during endovascular procedures, including TEVAR/EVAR procedures.

The Lunderquist Extra Stiff Wire Guides are both long and stiff; features that make them suitable for facilitating endovascular procedures that involve placement of large devices e.g., stent grafts in the aorta. The wire guides are not intended for coronary or neurovascular use.

The Lunderquist® Extra Stiff Wire Guides are 0.035 inch PTFE coated stainless steel wire guides consisting of a mandril and a 15 cm or 18 cm long coil. The mandril has a tapered end with a length of 11 cm and an additional 4 or 7 cm flexible tip. The Lunderquist wire guides are available in the following configurations:

Straight Lunderquist wire guides (TSMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil.

Curved Lunderquist wire guides (TSCMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.

Double Curved Lunderquist wire guides (TSCMG-/-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Double Curved Lunderquist wire guides have a large curve/J-curve radius of 75/15 mm.

Extended Double Curved Lunderquist wire guides (TSCMG-/-E-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Extended Double Curved Lunderquist wire guides have an extended large curve/J-curve radius of 55/15 mm.

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The Allure Hip Stems are intended to be used in total and partial (hemi-) hip arthroplasty to treat mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. The Allure Hip Stems are intended for uncemented use only.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision surgeries

The Intramedullary Plugs are intended for use with cemented hip stem prostheses to prevent uncontrolled diffusion of bone cement within the medullary canal.

This submission includes the Allure Hip Stems for cementless use and Intramedullary (IM) Plugs for use with cemented hip stem prostheses. Therefore, they are not meant to be used together, but the Allure Stems and the IM Plugs (when used with LINK cemented hip stems) are both used with the same previously cleared LINK systems (Prosthesis Heads and Vario Cups, BiMobile Dual Mobility System, MobileLink Acetabular Cup System) to create hemi-hip or total hip arthroplasty constructs.

The Allure Hip Stem is forged out of a Tilastan-S (Ti6Al4V) alloy. The Prosthesis Stems are proximally equipped with a TiCaP (Titanium-plasma + Calcium Phosphate) coating while the distal tip features a microporous surface with a HX (Calcium Phosphate) coating. The implants are available in different sizes and neck designs, standard or lateralized version and collared or collarless neck, allowing an accurate anatomical match for each patient.

The Allure Hip Stem is part of a mechanical reconstruction of the hip joint. The Allure Hip Stem forms a total hip arthroplasty (THA) when combined with a prosthesis head and an acetabular cup. Alternatively, a hemiarthroplasty (HA) is formed, when combined with the Vario-Cup System. The Hip Stem is intended for uncemented use.

The Intramedullary Plugs are used in combination with cemented implant components.

The Intramedullary Plugs are manufactured from ultrahigh molecular weight polyethylene (UHMWPE), and in sizes from 8 mm to 20 mm.

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