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The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: ·Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: · Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570mm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. - Two wavelengths CO2 and 1570 nm - Articulated arm - Footswitch - Delivery devices (CO₂ non-fractional applicators, Scanner CO₂/1570nm fractional applicator) Electrical specifications are: 100-230V ~ single phase, 50/60 Hz, Absorbed electric power 1500 VA (max)

The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The modification to the device consists in the increasing of the average output power from 6W to 10W.

The LipoAI is indicated for the surgical incision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The LipoAI is further indicated for laser assisted lipolysis.

The LipoAl is medical laser equipped with a short pulse 1444 nm Nd:YAG laser source. The device delivers the laser energy through a 600 um optical fiber. The fiber is protected by a small stainless-steel cannula (max. 1.4mm) and is inserted in the tissue through a small aperture in the skin. The DEKA LipoAl device consists of: An AC/DC power supply unit, CPU controller, LASER source, Cooling system, User interface with LCD touch screen, Beam delivery system. Laser activation is controlled by footswitch. Electrical specifications are: 200-240V ~ single phase, 50/60 Hz, Absorbed electric power 3200 VA (max)

The DEKA TIAC II RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The DEKA TIAC II massage device is intended to provide a temporary reduction in the appearance of cellulite.

The DEKA TIAC II is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite. The DEKA TIAC II consists of the following main components: - microprocessor-driven control unit - high-frequency electromagnetic energy generator - user interface with 10.4" color touch screen - 2 RF handpieces for application of radiofrequency - 2 integrated massaging balls handpieces Contact quality monitoring system is present for monitoring of the contact quality under the RF handpiece electrodes. The electrical specifications are 100-240Vac, 50/60Hz, 1500VA.

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) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. 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 lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, 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), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for benign pigmented lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser 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 AZ is a medical device equipped with Alexandrite 755nm 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 modifications to the device consist on a restyling of the device (chassis, cover plastics and GUI) and on modifications to Moveo handpiece (new spot sizes available and new optional spacer). The spot size and the fluences are within the range of the already cleared device (K181486). The optional spacer is made of a biocompatible material (Anticorodal 6082), already used in previously cleared devices for the same type of contact (K192539, K172362, K172362, K133895). The intended use of the modified devices, 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.

The DEKA SmartXide2 Trio CO2 laser is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The DEKA Smartxide2 Trio 940nm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures. The DEKA SmartXide2 Trio 980mm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source. The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory (handpiece/scanner/micromanipulator) connected to its distal end, or through a hollow waveguide. 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 waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating which is highly reflective at the intended wavelength of use. The waveguides used with DEKA Smartxided Trio are manufactured by Laser Engineering and have been cleared by FDA with K112166. The diode laser source can be provided in two alternative wavelengths: 940nm and 980mm. The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. The spot size is effectively the diameter of the fiber being connected to the system. Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the svstem. A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready. Overall weight of the device is 100 kg, and the size is 240 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A. The modification to the device is the addition of a hollow waveguide delivery system as an alternative to the articulated arm for the CO2 laser beam . It allows easier delivery of laser energy to the targeted tissue in some surgical procedures. The intended use of the modified devices, as described in the labelling, has not changed as a result of the modification.

The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.

Incision, excision, ablation, vaporization 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 DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. 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 DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.

755mn laser: 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 1 - VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm laser: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers 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, teleangiectasia, 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), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques. The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser 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. Pulsed light FT handpiece: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table: | Pulsed light | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions | |------------------|------------------|------------------|------------------|-------------------| | Wavelength range | | | | | | 500-1200nm | - | Skin Types I, II | Skin Types I, II | - | | 520-1200nm | - | Skin Type III | Skin Type III | Skin Types I, II | | 550-1200nm | Skin Types I, II | - | - | Skin Type III | | 600-1200nm | Skin Type III | - | - | - | | 650-1200nm | Skin Type IV | - | - | Skin Type IV |

The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece). The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition. The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide; it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the three available sources to the other by pressing a key on touch panel. Handpiece activation is either by footswitch or fingerswitch. The modifications to the device are two laser handpieces, allowing for a larger treatment area, 22mm and 24mm, and a change of maximum pulse repetition rate for some intermediate settings for the Nd: YAG laser source. The device hardware did not require any modification to support the new features. Minor changes to the software have been made in order to manage the new handpieces and the modified intermediate settings for the Nd:YAG laser source. The intended use of the modified device, as described in the labeling, has not changed as a result of the modifications.