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CoreLevée is indicated to be used for: - Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - Strengthening, toning and firming of buttocks and thighs.

CoreLevée is a non-invasive electromagnetic muscle stimulator that applies high-intensity electromagnetic field to the treatable body areas through two applicators. The coil enclosed in each applicator produces a magnetic field that induces electric currents within neuromuscular tissues. At its optimal level, these electric currents depolarize neuromuscular tissues causing effective muscle contraction. CoreLevée consists of a Main Body, a software integrated color-touch LCD screen, two applicators, three applicator fixing belts, and a patient switch. The Main Body allows the proper operation of the entire system. The LCD screen works as a control panel and displays step-by-step guides through the entire therapy procedure. The therapeutic parameters such as treatment time, location, and stimulation frequency and intensity are easily set using the touch screen and the dial knob on the device. The micro-controller within the software continuously monitors the device system for its operation and functional normalcies. Two applicators can be used alone or together on top of clothing. The device is a mobile standalone equipment with four wheels. The device housing protects the patient from electrical shock and mechanical injuries.

The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis. 1064nm in nanosecond mode, including microbeam handpieces: - Tattoo removal: dark ink (black, blue, and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of melasma 1064nm in Spectra (long-pulse) mode: - Treatment of wrinkles - Treatment of mild to moderate inflammatory acne vulgaris 532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Skin resurfacing procedures for the treatment of acne scars and wrinkles - Treatment of Lentigines - Treatment of Café-au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyperpigmentation - Treatment of Becker's Nevi, Freckles, and Nevi spilus

The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.

1064 nm The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick 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 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 mm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. 532 nm For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

The DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 mm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined 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 for either the 532 nm or 1064 nm wavelength. The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device. The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch. The DermaV laser system emits laser energy at 532 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.

755 nm: The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles. 1064 nm: The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick 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 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined 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 for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.

The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The LUTRONIC GENIUS Radiofrequency System consists of the system control module and RF power supply in a main body on locking castor wheels, a handpiece equipped with disposable handpiece tips with microneedle array, footswitch, handpiece hanger and holder, and an LCD touch screen control panel. The sterilized handpiece tips include the tip body containing the microneedle array and a protective cap. The treatment parameters are entered via a touchscreen console that also displays system output information during treatment. The microneedles come in light contact with the epidermis of the patient and minimally penetrate the epidermis during the treatment. Needle depth, Power level and Duration (Power x Duration = RF Energy), are userselectable via the GUI console. The RF Power output is controlled to insure for a given Duration that a determinate RF Energy is delivered to the 7x7 bipolar microneedle array of the handpiece tips. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin via the needles, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the needles.

The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows: The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: · Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: - · Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: - · Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI - Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: - · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV - Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III

The PICOPLUS Laser System is a surgical laser instrument. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to insure user safety and durability of use. The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system console, an articulated arm and attached handpieces.

The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.

The ACTION II Laser System is indicated for: coagulation, vaporization or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; keratoses; scar revision (including acne scars).

The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.

The R:GEN Laser System is indicated for use by an opthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment of Clinically Significant Macular Edema (CSME)

The R:GEN Laser System is a surgical laser instrument for use by ophthalmic physicians for performing selective retinal therapy (SRT) for treatment of Clinically Significant Macular Edema (CSME) which is a condition secondary to Diabetic Retinopathy. It is designed for use in a clinic or outpatient facility, or in Retinal Specialist's practice. The R:GEN Laser System is a Q-switched Nd: YLF (Neodymium-doped Yttrium Lithium Fluoride) laser with an emission wavelength of 527 nm (produced by second-harmonic generation). The R:GEN Laser System consists of a main laser, an optical fiber, delivery system including slit lamp, and a footswitch. The graphic user interface (GUI) screen of the control panel is equipped with an LCD (liquid crystal display) touch screen so that operators can easily adjust parameters for optimal settings. The software included provides all the functions, which are necessary to use the device. The GUI screen of the control panel allows the operator to set the treatment parameters, such as the laser energy for each patient. The GUI screen of the control panel also displays useful information about the system during operation. During operation of the R:GEN Laser System, all system functions are continuously monitored internally by a micro-controller and displayed to the operator.

The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins. The ADVANTAGE Laser System with the D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9. and 12 months. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). 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 ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, caféau-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

The ADVANTAGE Laser System with D1-1064 Handpiece is a treatment handpiece, intended to be used with ADVANTAGE Laser System 510(k) cleared in K113502 on April 5, 2012. The ADVANTAGE Laser System with D1-1064 Handpiece delivers laser energy through a 10 x 10 mm tip with a fluence of up to 100 J/cm2. The settings for this handpiece are pulse duration from 5-400 msec, and a pulse repetition rate up to 3 Hz maximum. The ADVANTAGE Laser System with D1-1064 Handpiece is water-cooled to provide active skin cooling.