Search Results
Found 3 results
510(k) Data Aggregation
(217 days)
The Boston PICO is indicated for surgical and cosmetic use in dermatology department, general surgery department and plastic surgery department, details are as follows:
1064 nm wavelength:
- Remove tattoos of all skin types (Fitzpatrick skin type I-VI) in the following colors: black, brown, green, blue and purple.
- Treat benign pigmented skin lesions of Fitzpatrick I-IV types.
532 nm wavelength:
- Remove tattoos of Fitzpatrick skin type I-III in the following colors: red, yellow and orange.
- Treat benign pigmented skin lesions of Fitzpatrick I-IV types.
Microbeam handpieces (1064nm and 532nm) are used for the treatment of wrinkles for skin types I-IV.
The Boston PICO is a multi-wavelength, pulsed laser system, and a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in 250ps(± 20%). The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer of the skin is renewed. The 1064 nm wavelength can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 532 nm or 1064 nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.
N/A
Ask a specific question about this device
(175 days)
The Boston Pico755 is indicated for the removal of tattoos and benign pigmented lesions, including but not limited to Ota nevus, Hori spots (Hori nevus), and melasma. The Boston Pico755 with the 2 mm and 6 mm handpieces and the handpieces with Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I-IV.
The Boston Pico755 is a medical solid-state laser equipment which is indicated for the removal of tattoos and benign pigmented lesions, including but not to limited to: Ota nevus, Hori spots (Hori nevus) and melasma. It has handpieces for the treatment of acne scars and wrinkles in skin types I-IV. The device is intended to be used in professional healthcare facilities by trained physicians only.
The subject device Boston Pico755 consists of main unit (including power module, laser module, control system and cooling system), a light guide articulated arm, a footswitch, a handpiece and protective Glasses. It is connected to supply mains directly through undetachable power cord and plug. There are 8 types of replaceable handpieces - Zoom S, Zoom X, M, M6, M8, M10, 755x, 755s, and operators can choose the appropriate handpiece according to treatment needs.
When the system automatically detects the model of the installed handpiece, it will display the corresponding treatment interface specific to that handpiece. Users can view or adjust relevant parameters such as wavelength, fluence, energy, spot size, and repetition rate directly from the interface.
After turning on the device, set the Wavelength, Fluence, Frequency, Spot Size, etc. to be used then press the Footswitch in the READY state, the laser will be energized and transferred through the Articulated Arm and handpiece. The cooling system controls the heating caused by the laser output.
N/A
Ask a specific question about this device
(199 days)
The Boston iFace is intended to be used for heating to rise tissue temperature, which is used for selected medical conditions, such as temporary relief of pain, muscle spasms, and promotion of local circulation.
The Boston iFace is mainly composed of a host, a footswitch, a handpiece, a hand swtich, a power cord, tip connectors, tips and a trolley.
The Boston iFace is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy.
N/A
Ask a specific question about this device
Page 1 of 1