Search Results
Found 7061 results
510(k) Data Aggregation
(236 days)
Ask a specific question about this device
(30 days)
Ask a specific question about this device
(30 days)
Ask a specific question about this device
(118 days)
Ask a specific question about this device
(210 days)
Ask a specific question about this device
(85 days)
The PICO-K is intended for use in the following indications at the specified wavelength:
1064 nm wavelength
- Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
- Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
- Treatment of acne scars in Fitzpatrick Skin Types II-V
- Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength
- Tattoo removal in Skin Types I - III
- Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
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. Three different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, and MLA handpiece. Each handpiece integrates and aiming beam that shows the treatment area.
The Nd:YAG laser surgical system employs a solid-state laser with a medium of Nd:YAG at 1064 nm and KTP at 532 nm. The energy from the 1064 nm wavelengths emitted by the laser is directed at the cells or tissues of the skin, raising the temperature of the targeted tissue according to the Selective Photothermolysis Theory. This selective heating of the tissue results in the cutting, destruction, or removal of the tissue through the heat energy produced by the laser.
PICO-K employs a patented resonator design with optics aligned under controlled thermal lensing conditions. At high repetition rates (8–10 Hz), thermal lensing of the Nd:YAG rod can degrade beam quality in conventional systems. In PICO-K, the lamp frequency is fixed at 8–10 Hz, optical alignment is optimized under these conditions, and laser emission is generated only at divisor frequencies (1, 2, 3, 4, 5, 8, 9, 10 Hz).
N/A
Ask a specific question about this device
(91 days)
The Paruu Wearable Breast Pump is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Paruu Wearable Breast Pump is a powered breast pump intended to be used by lactating women to express and collect milk from their breast in home healthcare environment. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The breast milk is collected in a milk collector. The device consists of a pump motor (main unit), milk collection set (flange, diaphragm, duckbill valve, milk collector, flange cover) and accessories (flange insert, charging cable). The milk collection set and flange insert can be purchased separately.
The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed. The user interface consists of buttons allowing the user to switch between modes and control the vacuum pressure levels, and LED display that providing information on current mode, level, timer and battery status.
The device includes 23 different models, and based on their technological characteristics, are divided into two broad categories – P16 series consisting of models P16, P16-A, P16-B, P16-C, P16-D, and P20 series consisting of models P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D. The models within each series vary in terms of their external color. All device models include 4 working modes (Stimulation, Expression, Two-in-one and Dual frequency for P16 Series and Stimulation, Expression, Lactation, and Traction for P20 Series) and 12 suction levels for each mode.
To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on 3.7V rechargeable lithium battery. The rechargeable battery can be charged from the external power adapter (not included with the device) through the provided charging cable. All milk contacting components of the device are compliant with 21 CFR 177.
N/A
Ask a specific question about this device
(28 days)
Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, 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.
Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The device is to be used by persons in the age range of 18-65 years with fair up to medium brown skin tones, and naturally dark blond, brown, dark brown and black hair.
The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited.
The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment.
N/A
Ask a specific question about this device
(251 days)
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
This product consists of frame, wheels, seat, armrest, backrest, headrest, battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The backrest, headrest and armrest can be adjustable. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is steel and aluminum. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 135KG. Only for one person sit.
N/A
Ask a specific question about this device
(285 days)
The Pression Wave PRO External Counter-Pulsation System is indicated for the treatment of chronic stable angina (CSA) that is refractory to optimal anti-anginal medical therapy and without options for revascularization in adult patients that weigh greater than 40kg. In addition, it is intended for use in healthy adult patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the supervision of a healthcare professional.
External counter-pulsation (ECP) as a general technology involves the application of pressure to the patient's legs using inflatable cuffs or sleeves to enhance perfusion at the heart. ECP using the Wave PRO involves wrapping the patient's calves in sleeves containing inflatable bladders, which compress the calves in sync with the patient's cardiac cycle. During diastole, a series of five bladders within the sleeves inflate sequentially from the patient's ankles towards their knees. This compression results in diastolic augmentation, which is observable from the pulse data obtained using a finger-tip PPG sensor. During the diastolic phase, the heart is relaxed, allowing for coronary perfusion to the cardiac muscle. By compressing the inflatable bladders during this portion of the cardiac cycle, aortic retrograde flow is increased, allowing for enhanced coronary perfusion.
The Pression Wave PRO System consists of three primary subsystems: 1) the Compression Control System, which controls the flow of compressed air to the sleeves, measures the phase of the cardiac cycle, and provides the graphical user interface (GUI); 2) Patient-Worn Calf Sleeves, which direct the compressive force of compressed air, delivered comfortably and consistently, to the patient's calf muscles; and 3) the Compression Timing Algorithm (Software), which determines when the patient's heart is in diastole, using a photoplethysmography (PPG) sensor, and controls the timed application of compression to the patient's calf muscles.
N/A
Ask a specific question about this device
Page 1 of 707