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The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: 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 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 DEKA Smartperio 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.

ERISE Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectas; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.

ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: - . A connector to connect to the console - A cord where electrical cables and hydraulic tubes pass in - A plastic shell - . A Laser cavity - . A mechanical shutter - . An optical guide - . An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm) The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.

The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications. Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to: - · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement) - · Biopsies - Frenectomy, Frenum release - Gingivoplasty - Papillectomy - · Vestibuloplasty - · Hyperplasia - Operculectomy - · Drainage (abscess) - · Flap surgerv - · Fibroma (nonmalignant tumor, mucosa, tongue) - Epulis - · Aphthous ulcers - · Removal of soft tissue, cysts, and tumors · Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).

DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.

The DEKA Motus AX laser system is indicated for: 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).

The DEKA Motus AX is a medical device equipped with a 755nm solid state laser source. The laser source delivers 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. Handpiece activation is either by footswitch or fingerswitch.

The DEKA Synchro Repla:Y family of laser systems is indicated for: 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 I - VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). l 064nm 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 lesions to reduce 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<br>wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions | |----------------------------------|------------------|------------------|------------------|-------------------| | 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 DEKA SmartXide2 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 940nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures. The DEKA SmartXide2 980nm diode laser is indicated for 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, urology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

The DEKA SmartXide" system 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 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. An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations. The DEKA SmartXide2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator. The scanning units move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation. The CO2 laser focalized on very little spots by the micromanipulator and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation. The diode laser source can be provided in two alternative wavelengths: 940nm and 980nm. 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 system. 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 95 kg, and the size is 210 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source. The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end. 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 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D). Electrical requirement is 115Vac 50/60Hz, 750VA.

The Deka Synchro FT is indicated for the following treatments: Nd: YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. Pulsed light attachment: 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<br>wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions | |----------------------------------|------------------|------------------|------------------|-------------------| | 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 FT is a platform which can be equipped with an internal hi-power long pulse Nd:YAG laser module and a pulsed light handpiece (FT handpiece). SynchroFT with the long pulse Nd:YAG module comes with a wide range of interchangeable, quick release handpieces with electronic spot recognition. The FT handpiece is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the two available sources to the other by pressing a key on keyboard. Handpiece activation is either by footswitch or fingerswitch. Overall weight of the device is 65 kg, and the size is 100 cm x 50 cm x 83 cm (H x W x D). Electrical requirement is 230VAC, 16A, 50-60 Hz, single phase.

The SmartXide 50 HS/MS system with its delivery accessories is a medical device indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery and genitourinary surgery.

SmartXide 50 HS/MS is a surgical CO2 laser with 50W of maximum power in continuous mode. The laser system is produced and sold with an internal predisposition for scanning system (HiScan Surgical for SmartXide HS, MiniScan Plus for SmartXide MS). Laser activation is by footswitch. Overall weight of the laser is 43 kg, and the size is 160 cm x 48 cm x 55 cm (H x W x D). Electrical requirement is 115VAC, 6A, 50-60 Hz, single phase. The wavelength of this laser is 10.600nm. This wavelength is mostly absorbed by water and that makes this laser particularly suitable for soft tissue surgery. The CO2 laser radiation is delivered to the treatment area through the handpiece. The handpiece is attached to the distal end of the articulated arm, which is a permanently mounted laser delivery system of the system. 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 however the arm is oriented. The field of action of the articulated arm covers a radius of approximately 80 cm, the transfer efficiency of power is greater than 85%. The loss of 15% is balanced by a suitable calibration of the internal power meter. An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations. Emission parameters are selected on the front panel while emission activation is by the footswitch. The on-off switch and emergency switch are also located on the front panel of the system. 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. The CO2 laser microsurgery is done with microspot micromanipulators and scanning systems. The CO2 laser focalized on very little spots (140-250um) and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation. In the SmartXide 50 HS/MS series, the electronic controller of the scanner has been integrated in the laser system with touch screen settings. The scanning systems move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation. The high Power Density reached though little spots and typical of the cutting, are thus well controlled by the operator, and the tissue destruction happens in a very quick, delicate and precise way, reducing drastically the surgery time and limiting the lateral thermal damage and the negative phenomenon of carbonisation, with evident advantage for the patient and for the surgeon as well. Both scanning units can be used together with Deka micromanipulator EasySpot. Easyspot has a single ring nut rapid focalization system that allows to focalize the beam to the same focal length of the microscope and fix the position with a mechanical block. In this way the micromanipulator "remembers" the focus position, still allowing eventually the surgeon to defocus the beam from the same ring nut. Thanks to its joystick, it is possible to regulate the mechanical tension and the maximum work field in order to easily control and never "loose" the beam even inside small size faryngoscopes. On top of the joystick Easyspot can mount a remote control specially conceived to command top level scanning systems (HiScan Surgical). It allows the surgeon to have under direct control the more useful electronic scanning functions (rotation and dimension of the figures, scan off-scan on, centering) without moving his eyes from the microscope.

The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.

The Minisilk_FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200 nm. Emission activation is by footswitch. Overall weight of the system is 16 kg, and the size is 22x37x45 cm (H x W x D). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.