Search Results
Found 1770 results
510(k) Data Aggregation
(269 days)
Ask a specific question about this device
(293 days)
Ask a specific question about this device
(73 days)
Ask a specific question about this device
(89 days)
Ask a specific question about this device
(27 days)
Ask a specific question about this device
(265 days)
Ask a specific question about this device
(88 days)
The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm
The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI).
532 nm
The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Medical Ultra-Pico Laser Treatment System is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, a light guide arm, a light guide arm tip, a spot regulator and a footswitch. The laser output is delivered to the skin through the light guide arm delivery system terminated by the light guide arm tip. The energy and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. For treatment, the user can select the appropriate frequency and the related output energy value by pressing plus and/or minus button from the LCD display/Touch Pad located on the front of the main unit.
N/A
Ask a specific question about this device
(88 days)
The Medical Alexandrite and Nd:YAG laser Therapy 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 benign vascular lesions (such as portwine stains, hemangiomas, telangiectasias)
1064nm
- Removal of unwanted hair, for stable long term or permanent hair reduction. 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. Benign pigmented and/or benign vascular lesions, such as, but not limited to port-wine stains, telangiectasia, venus lake, leg veins and spider veins. Benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, skin tags, keratosis.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
- Treatment of wrinkles.
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
The Medical Alexandrite and Nd:YAG laser Therapy System is a Nd: YAG and Alexandrite laser operating at wavelengths of 1064 nm and 755 nm. The Medical Alexandrite and Nd:YAG laser Therapy System consists of the main unit, optical fiber, handpiece, treatment tip, footswitch, and handpiece holder and other accessories. The laser output is delivered to the skin through the optical fiber terminated by the handpiece. The Medical Alexandrite and Nd:YAG laser Therapy System is used for a variety of medical purpose. For treatment, the user can select the appropriate wavelength and the related output energy value by pressing UP and/or DOWN button from the LCD display/Touch Pad located on the front of the main unit.
N/A
Ask a specific question about this device
(58 days)
Meniscus Versaflex is indicated for repair of the meniscus.
Meniscus Versaflex - All Inside Meniscal Suture with Bendable Tip is an arthroscopy suture, non-absorbable, assembled in an insertion device. The inserter mechanism can be molded for better access to the posterior areas, medium region and anterior third of meniscus, with use of a bending tool and the options (models) of general use and reverse. Each device has two implants of non-absorbable polymer PEEK, previously connected with a UHMWPE suture and pre-assembled in an insertion system. The inserter is offered in a curved and reverse curved configuration. It is provided in sterile condition sterilized by Ethylene Oxide.
N/A
Ask a specific question about this device
(155 days)
The MEDRAD® MRXperion MR Injection System is a syringe‐based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners. Only trained healthcare professionals are intended to operate this device. For a complete list of compatible contrast agents for use with the MEDRAD MRXperion MR Injection System, refer to the MRXperion MR Injection System Operation Manual. The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
The MRXperion Injection System is a software-controlled, electromechanical medical device used for the administration of intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) procedures. Commonly referred to as an automated injection system, it is designed to allow a user to fill disposable syringes and then to perform an injection with a user-programmed volume and flow rate.
The MRXperion Injection System is comprised of a Scan Room Unit (SRU), Control Room Unit (CRU) and Single Use, Disposable Syringe Kit.
The SRU is located within the scan room whereas the control room unit is not. The SRU, via a wired connection, interfaces with the control room unit. The CRU, also known as the workstation, includes a graphical user interface for the injector. The operator can use the touchscreen display to manage protocols and initiate and execute injections. However, the SRU can be used to also initiate and execute injections.
The fluids are delivered from a single use only, sterile disposable set that includes one 65 mL syringe for contrast media and one 115 mL syringe for saline.
The injection system is intended to be used in an MR suite. The MR suite may be located in a mobile medical imaging trailer. The injection system is intended to be operated by personnel with training and experience in MR procedures and use of MR injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use with the general patient population, including adults and pediatrics.
The MRXperion Injection System subject to this submission includes modified hardware and software as compared to the most recent clearance (K182276). The submission also includes an additional connectivity accessory, Imaging System Interface (ISI2) Module. The design changes do not involve any changes to the MRXperion MR Injection System Syringe Kit.
N/A
Ask a specific question about this device
Page 1 of 177