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Ask a specific question about this device

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BELLUS-Q, Q switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

1064 nm wavelength in Q-switched mode:

• Removal of dark (black, blue, brown) tattoo ink
• Treatment of nevus of ota
• Treatment of common nevi
• Removal and lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma
• General dermatology indications: Incision, excision, ablation and vaporization of soft tissue

1064 nm wavelength in GENESIS mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532 nm wavelength in Q-switched mode (nominal delivered energy of 585 nm and 650 nm with the optional 585 nm and 650 nm dye converter handpieces):

• Red, tan, purple and orange tattoo ink removal
• Sky blue (light) tattoo ink removal
• Green tattoo ink removal
• Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
• Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
• Seborrheic Keratosis
• Treatment of post-inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Removal of epidermal pigmented lesions

The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The system includes several safety features, including use of key switch, an interlock, emergency stop button, and need to press a footswitch in order to activate the laser. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Five different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, MLA handpiece, 585 Dye handpiece, and the 650 Dye handpiece. In addition, the system can operate in different modes, including single pulse, PTP, 3-pulse, 6-pulse, and genesis modes. Each handpiece integrates and aiming beam that shows the treatment area.

The Nd:YAG laser surgical system utilizes a solid-state laser medium of Nd:YAG at 1064 nm and KTP at 532 nm. The 1064 nm and 532 nm wavelengths interact with targeted skin cells or tissues, primarily leveraging the Photothermolysis Effect in Q-switched nanosecond pulse modes. This selective photothermolysis mechanism enables controlled thermal absorption within target chromophores, leading to coagulation, denaturation, or vaporization of melanin-containing cells while preserving surrounding tissues. The laser energy is effectively absorbed by pigmented lesions, allowing for precise and efficient treatment in dermatological applications.

The system also supports Dye handpieces, which enable the use of 585 nm and 650 nm wavelengths by converting 532 nm light. These wavelengths have greater absorption for different specific pigment-related lesions, expanding the system's versatility in medical and aesthetic procedures.

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The BCM2 is intended for use, under the direction of a physician, for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease (ESKD) including those receiving maintenance dialysis.

The device does not generate any real-time alarms and outputs from the device should be used in the context of all clinical data to assess a patient's fluid status.

The device is intended for use in patients 18 years and older.

The BCM2 is a multifrequency bioimpedance device that can be used by a clinician for the noninvasive intermittent measurement of fluid status in patients with end-stage kidney disease, including those receiving maintenance dialysis. A physician or designated healthcare professional is responsible for interpreting data from the device to determine what action is required as a result of changes in the measurements.

To assess a patient's hydration status, the BCM2 measures impedance by applying a low-level signal (50–800 µA) for less than 10 seconds at 50 different frequencies from 5 kHz to 1,000 kHz. Measurements are performed by dialysis clinicians (e.g., dialysis nurses, patient care technicians) in a healthcare environment such as a dialysis clinic or hospital.

In the normal clinical workflow, the BCM2 provides the following output parameters:

• Overhydration (OH)
• Urea distribution volume (V)

The following calculated and derived parameters are also available:

• Extracellular water (ECW)
• Intracellular water (ICW)
• Total body water (TBW)

The BCM2 system consists of the BCM2 touchscreen console and the electrode set. The BCM2 console powers and measures the bioimpedance spectroscopy frequencies to assess fluid parameters. The device can also be operated in battery mode. Battery mode provides flexibility when moving between patients. The battery charge status is shown in the upper corner of the display regardless of which power source is being used. The power supply connection is located on the rear of the console.

The Calibration Box employs different resistors to calibrate the entire range of the BCM2's measurement (5 kHz to 1,000 kHz). Impedance measurements are performed for each resistor for all frequencies and the data is verified against an expected tolerance range. After the BCM2 has been calibrated, the Test Box is used to verify that the device is functioning properly.

The BCM2 will be available in one (1) configuration for sale within the U.S.

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BEE HA cages are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. BEE HA cages are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.

The subject BEE HA cage is an anterior cervical interbody fusion device. BEE HA cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The subject device has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device. Additionally, the device contains four (4) titanium alloy (Ti6Al4V per ASTM F136) pins to provide imaging visibility for device positioning.

BEE HA cages are offered in several adaptive sizes with varying footprints and lordotic angles to accommodate patient anatomy. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form.

BEE HA cage is intended for single use only and is provided sterile, using gamma irradiation.

The purpose of this traditional 510k is to expand the size range offerings for the previously cleared BEE HA.

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The Biomoneta Avata Rx is an over-the-counter (OTC) medical recirculating air cleaner intended to remove particles for medical purposes. The device is intended for indoor use only.

The Biomoneta Avata Rx has been demonstrated to reduce Staphylococcus epidermidis, Klebsiella aerogenes, and MS2 bacteriophage by > 5 log when operated at its highest fan speed for 60 minutes.

Note: The designation "Rx" in the product name is part of the trade name and does not indicate prescription status.

Performance was validated in controlled test chambers measuring 9.1 ft × 9.1 ft × 7 ft (bioaerosol) and 12 ft × 12.5 ft × 15 ft (particle reduction).

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The BrainsWay Deep TMS™ System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The BrainsWay Deep TMS™ System is also indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).

The BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure.

The BrainsWay Deep TMS™ System is composed of the following main components:

1. Cart
   a) TMS Neurostimulator
   b) Cooling System
   c) Positioning Device
2. Helmet
   a) Aiming Apparatus (i.e., ruler/grid)
   b) Electromagnetic Coil (H Coil)
   c) Cap

The BrainsWay Deep TMS™ System is identical to the previously cleared BrainsWay Deep TMS™ Systems.

The purpose of this 510(k) submission is to enable modifications to the device software and for use as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21 years).

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