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Diode Laser Hair Removal Machine (Model: GLD01) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

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 Diode Laser Hair Removal Machine (Model: GLD01) consists with the power system, microprocessor controller system, operation and screen system, cooling system, laser module and security alarm system. The microprocessor control the laser power, which can provide the constant current for the laser module. The inner high energy diode, from the laser module, transform the electronic to light energy, which output the constant laser with wavelength.The laser light on the skin by leaded crystal, penetrate into the deep tissue of the skin. The light energy is absorbed and then turned into the thermal energy, which can destroy the hair follicle tissue, make it gone and never grow again.

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Advanced Bipolar: The Voyant electrosurgical generator is indicated for use with advanced bipolar Voyant devices in open and minimally invasive procedures where the ligation of vessels up to and including 7mm in diameter and tissue bundles is desired.

NOTE: For indications specific to each Voyant device used with the Voyant generator, refer to each device's Instructions for Use (IFU).

Monopolar/Bipolar: Intended to provide energy to standard monopolar and bipolar surgical accessories.

The Applied Medical Voyant Electrosurgical Generator (EA030) is a reusable, electrically isolated, microprocessor-controlled power supply intended to deliver radiofrequency (RF) energy for electrosurgical applications. The system provides energy output to compatible monopolar, bipolar, and Voyant advanced bipolar instruments for the cutting, coagulation, and sealing of vessels and tissue bundles. The Voyant EA030 operates outside the sterile field and interfaces with active surgical instruments that operate within the sterile field. The system comprises integrated mechanical, electrical, and software components, constructed from various metals and polymers. It features a front-panel LCD touchscreen that enables users to view, navigate and adjust operating modes and system settings.

Voyant EA030 is designed to function as part of a system that includes optional accessories such as active devices, footswitches, and patient return electrodes. These components work together to ensure safe and effective energy delivery during surgical procedures.

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Chex-All® Sterilization Pouches and Tubes are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

Hospital size sterilizer cycles

• Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
• Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

Tabletop sterilizer cycles:

• Pre-vacuum steam at 132°C (270°F) for 4 minutes; 30 minutes dry time

Ethylene Oxide sterilization cycles:

• Ethylene Oxide (EO) with a concentration of 736 mg/L at 55°C (131°F) and 50% to 60% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

Chex-All sterilization pouches and tubes can be used for steam sterilization of devices with lumens at maximum load as the following:

Metal lumen: 7 inch long, 3.2mm internal diameter
Plastic lumen: 5 inch long, 2.0 mm internal diameter.

Suitable Lumen cycles:
Hospital size sterilizers: pre-vacuum cycles with 132°C-4.0 min exposure (20 minutes dry time) and 135°C-3.0 min exposure (16 minutes dry time).
Table-top sterilizers: pre-vacuum cycle with 132°C-4.0 min exposure (30 minutes dry time).

Chex-All sterilization pouches and tubes can be used for steam sterilization in double pouch configuration, in gravity 250°F-30 min exposure cycles (25 minutes dry time) and in pre-vacuum 270°F-4 min exposure cycles (20 minutes dry time).

The Process chemical indicators on the Chex-All sterilization pouches and tubes are intended to demonstrate that the device has been exposed to the steam or EO sterilization process and to distinguish between processed and unprocessed pouches. The chemical indicators change from crème to gray/black after exposure to steam and from beige-pink to green after exposure to ethylene oxide.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and to maintain sterility (SAL≥10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 30 months after steam sterilization and 12 months after EO sterilization.

The maximum pouch load is 2.65 lb. (1.2 kg) or less. The maximum pouch load for table-top sterilizers is 1.10 lb. (0.5 kg) or less. The maximum pouch size for use in table-top sterilizers is 13"x18".

The Chex-All® Sterilization pouches and tubes are made from a medical grade porous paper thermally sealed to a plastic film on the left, right, and bottom of the pouch. The top side is open to insert medical devices to be sterilized and to seal the pouch. They are available either pre-manufactured self-seal or heat-seal sizes or in a roll of heat-seal tubing for the customer to cut the pouches to their required size.

The pouches also contain chemical process indicators used to demonstrate that the pouches have been a subject of either a steam or ethylene oxide sterilization process.

All Chex-All sterilization pouches and tubes are flat and include the following products: Chex-All Heat-seal sterilization pouch, flat; Chex-All Heat-seal sterilization tube, flat, sold in rolls; Chex-All II Self-seal sterilization pouch, flat; Chex-All III Self-seal sterilization pouch, flat.

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Kii Structural Balloon Access System is indicated for use in patients undergoing laparoscopic surgery requiring a path of entry and/or tissue retraction of the extraperitoneal space.

Applied Medical's Kii Structural Balloon Access System provides a path of entry and/or tissue retraction for laparoscopic procedures in the extraperitoneal space. The system is provided sterile.

The system is composed of four main components:

• An obturator that facilitates insertion of the system through an incision.
• A cannula with bolster and attached balloon, encased within a perforated sheath.
• A seal which maintains insufflation.
• An inflation bulb that is used to manually inflate and deflate the balloon.

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The Moses fibers are intended for use with compatible laser systems in surgical procedures involving endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue, and lithotripsy of calculi in the medical specialty of urology.

The Moses D/F/L Laser Fibers are single-use, straight-firing delivery devices that transfer laser energy from the laser console to the treatment site. The laser energy travels within the fiber's silica glass core and exits through the distal end of the fiber. The Moses 200 D/F/L Fiber consists of a Ball Tip which aids in the passability of the small core fiber through a deflected flexible endoscope. Moses 365 D/F/L and Moses 550 D/F/L Fibers have a flat distal tip. The Moses Fibers also include an embedded RFID Chip, allowing the Laser Console to recognize fibers and limits the fibers to a single use. The Moses fibers are available in a single, box-one configurations. The Moses fibers are compatible with the (Lumenis) Pulse 120 Laser System, used for the energy delivery of the Holmium Laser Energy (Ho:YAG) from the Console. All Moses fibers have a 3-year shelf life and are provided EtO Sterilized.

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The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.

The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.

The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:

• Start or pause treatments
• Select treatment zones
• Check battery status
• View remaining session time

The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.

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The BD Alaris™ Pump Infusion Set is indicated for pump use by experienced healthcare professionals within healthcare facilities through intravenous, intra arterial and subcutaneous routes for adults, pediatrics and neonates or irrigation of fluid spaces for adults. Based on clinical discretion these sets can be used for temporary intravenous gravity infusion.

The subject BD Alaris™ Pump Infusion Set is a single-use infusion set incorporating a spiked drip chamber on the proximal end, which is inserted into a fluid container, and a male luer lock connector on the distal end which connects to a patient's access device. The spike cap and the male luer lock cap maintain sterility of the fluid path prior to use. The BD Alaris™ Pump Infusion Set is supplied fluid-path sterile using gamma irradiation and is non-pyrogenic. The subject BD Alaris™ Pump Infusion Set incorporates a pump segment designed to interface with the BD Alaris™ Pump Module for administration of fluids, medications, and parenteral nutrition through clinically acceptable routes of administration.

The BD Alaris™ Pump Infusion Set is available in six (6) configurations incorporating variations of the following components: roller clamp, pinch clamp, slide clamp, SmartSite™ Y-site(s), back check valve, and inline filter.

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The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It is further indicated for Fractional Skin Resurfacing.

The ellacor System with Micro-Coring Technology removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm² areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The ellacor System with Micro-Coring Technology mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.

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The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem is a handheld powered microneedling device consisting of a rechargeable motorized handpiece and disposable, single-use needle cartridges (12-pin and 36-pin). Microneedles are made of surgical-grade stainless steel (304) and are gamma sterilized.

Design modifications include:

• Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
• Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.

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Stellar Imaging System is intended to provide real-time visible and near-infrared imaging in minimally invasive procedures.

Upon intravenous administration and use of an ICG agent consistent with its approved label, Stellar Imaging System is used to perform fluorescence imaging visualization of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts.

Upon interstitial administration and use of an ICG agent consistent with its approved label, the Stellar Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Stellar Imaging System comprises Image Processing Unit, Light Source, Camera Head, Laparoscope and relevant accessories. During surgical procedures, Stellar Imaging System is used to provide real-time 3D visible and fluorescence imaging in endoscopic surgery.

The Stellar Imaging System including the laparoscope is designed to work with an approved infrared dye (Indocyanine green (ICG). ICG may be excited at excitation at either 785 or 805 nm. The System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye via the camera head. Fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow, etc.

The System allows the capture of normal (white) light image in parallel with the fluorescence image and displays both to the surgeon to provide a view of the anatomy. In addition, the System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

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