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The DEKA BlueBeam is a medical device intended for incision, excision, vaporization, ablation, hemostasis and coagulation of body soft tissue.

The DEKA BLUEBEAM is a diode laser engineered to enhance performance in surgical applications. The DEKA BLUEBEAM electrical specifications are: 100-230V~, 50/60Hz, 300VA.

• The DEKA LOTUS 570mm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. · The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins. · The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the noninvasive treatment of mild to moderate facial wrinkles and rhytides.

The DEKA LOTUS is a device provided with two pulsed light handpieces and a RF handpiece. The two pulsed light handpieces have a built-in cooled waveguide which differ in emission spectrum, connected to the main unit through a flexible multifunctional cable. The handpiece uses a linear Xenon flashlamp, emitting a broad spectrum of electromagnetic radiation (light) when energized. The RF handpiece produces a particular electric current at 1MHz that induces a molecular oscillation on the cells, raising their temperature locally. The RF current flows through the special electrodes, forming a homogeneous heat area. The modifications to the device respect to DEKA LOTUS (K233473) consist of replacement of the filter of 590nm Intensed Pulsed Light Handpiece with a 570nm filter. The intended use of modified device, as described in the labelling, has changed as a result of the modifications. Labelling itself has been updated accordingly.

MOTUS PRO family is a medical laser family intended for: Alexandrite 755nm laser source: - Temporary hair reduction. - Stable long term or permanent hair 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 I-VI) included tanned skin. - Treatment of benign pigmented lesions. - Photocoagulation of benign dermatological vascular lesions (such as port wine stains, hemangiomas, telangiectasias). Nd:YAG 1064nm laser source: - Removal of unwanted hair for stable long term or permanent hair reduction and for treatment of PFB. The laser are indicated on all Skin Types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to, port wine stains, hemangioma, warts, teleangiectasias, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. - The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patient with lesions that have not responded to other treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles.

MOTUS PRO family is a medical laser family equipped with Alexandrite 755mm laser and Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The device available with Alexandrite source only has the brand name MOTUS PRO AX. The modifications to the device respect to DEKA Motus AZ (K211821) consist of a restyling of the device (chassis, cover plastic and GUI) and on modification to spot size ranges (new spot size available), pulse duration, 755mm maximum fluence and maximum pulse repetition rate. The modified specifications are within the range of the already cleared reference device (K233090). The intended use of modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since clearance of predicate device and reference device and considered as minor changes.

785 nm laser source Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064 & 532 nm laser sources in Q-Switched, nanosecond mode Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to: 532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - · Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos - · Treatment of benign vascular lesions including, but not limited to: - port wine birthmarks - telangiectasias - spider angioma - Cherry angioma - Spider nevi - · Treatment of benign pigmented lesions including, but not limited to: - cafe-au-Iait birthmarks - Ephalides, solar lentigines - senile lentigines - Becker's nevi - freckles - common nevi - nevus spilus - Ota Nevus - · Treatment of seborrheic keratosis - · Treatment of post inflammatory hyperpigmentation - · Skin resurfacing procedures for the treatment of acne scars and wrinkles. 1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: - · Removal of dark ink (black, blue and brown) tattoos - · Removal of benign pigmented lesions including; - nevus of Ota - Café au lait spot - Ephalides, solar lentigo (lentigines) - Becker Nevus - Nevus spilus - · Treatment of common nevi - · Removal or lightening of unwanted hair - · Skin resurfacing procedures for the treatment of acne scars and wrinkles 1064nm laser source in thermal mode (long-pulse) Intended for: - Treatment of wrinkles - · Treatment of mild to moderate inflammatory acne vulgaris

TORO device is a DEKA laser system with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration. The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in Q-switched mode, and Ti:Sapphire laser at 785 nm operating in the Picosecond pulse mode. The Q-switched laser at 1064 nm can also operate in Thermal mode, delivering pulses of hundreds of microseconds. The laser beam generated by the source is then optically coupled to the articulated arm with a handpiece plugged at its end and delivered to the Patient.

The Nirvana device is indicated for hair removal and 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 NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.

The SMARTXIDE PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

SmartXide PRO is a 10.6um carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues. Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields. The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing. The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit. The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.

Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing. The overall weight is approximately 62 kg and the sizes are 42 x 122 x 54cm (W x H x D) with folded articulated arm. Electrical requirements: 100-230V ~ 50/60Hz, 1200VA (max).

The LILY device is indicated for muscle conditioning to stimulate healty muscles. The device is not intended to be used in conjunction with therapy or treatment of medical disease or medical conditions of any kind. The device is intended to be operated by a trained professional who is present to monitor treatment.

The DEKA LILY device consists of a main unit that generates electrical pulses and delivers rectangular biphasic waveforms via electrodes incorporated in an EMS applicator connected to the main unit. The delivery of the electrical energy is controlled by a footswitch. The DEKA LIL Y is provided with an applicator to perform EMS (Electrical Muscle Stimulation). The applicator is provided with two different tips: Large and Medium, used to treat areas having different sizes, which include 3 stainless-steel equidistant electrodes. The Applicator is directly applied on the area to be treated and moved by the operator across the skin. The overall weight is approximately 62 kg and the sizes 47cm x 56cm x 106cm (L x W x H). Electrical requirements: 115V, 50/60Hz, 2300VA.

The DEKA SIMON device is intended for - Prevention or retardation of disuse atrophy - Maintaining or increasing range of motion - Muscle re-education - Relaxation of muscle spasms - Increasing local blood circulation - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

The DEKA SIMON is a device provided with 4 applicators by 2 electrodes each intended to employ EMS (Electrical Muscle Stimulation) technologies for various medical applications. The DEKA SIMON consists of: - an AC/DC power supply unit, - EMS driving electronic board - CPU controller; - user interface with LCD touch screen, - 4 EMS applicator with interconnecting cables The modifications to the device consist of a restriction of indications for use (removal of TENS mode), a restyling of the device (chassis, cover plastics and GUI) and of modifications to the applicator (different dimensions). The indications for use of the modified device, as described in the labelling, has been restricted to those referred to EMS mode only as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.