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Dental Soft Tissue Indications Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - Fibroma removal - · Frenectomy - · Frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - Gingivoplasty - · Gingival incision and excision - Hemostasis and coagulation - · Implant recovery - · Incision and drainage of abscess - Leukoplakia - · Operculectomy - Oral papillectomies - Pulpotomy - Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Treatment of aphthous ulcers. - · Vestibuloplasty - · Tissue retraction for impression - · Lesion (tumor) removal. Laser Periodontal Procedures. - · Laser soft tissue curettage. - · Laser removal of diseased, Inflamed and necrosed soft tissue within the periodontal pocket. - · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. · Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) · Reduction of bacterial level (decontamination) and inflammation Pain therapy · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

The Gemini 2 810+980 Soft Tissue Laser is an 810+980nm soft tissue laser intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue and for pain relief using Photobiomodulation. The Gemini 2 810+980 Soft Tissue Laser operates at a wavelength of 810±10nm or at 980±10nm or a combination of both 810+980nm, with a maximum average power output of 2.0 watts ± 20%. The system also contains a 2mW, 650nm laser diode coupled to the same fiber optic cable to produce a red aiming light for the infrared laser beams. The laser energy is generated in an internal laser module and is then channeled through a flexible optical fiber that is permanently connected to a hand piece. Single-use disposable tips, or Photobiomodulation (PBM) adapters, become the laser aperture of the device when they are optically coupled to the fiber in the hand piece. The disposable tips and Photobiomodulation tips are interchangeable and provide a method of delivering laser energy to the target area. The laser unit is comprised of a molded plastic housing that contains: the laser module, main PCB with integrated MCU and laser controller, an electroluminescent display connected to an interface PCB, a touch sensitive graphic user interface with status indicators, and a rechargeable lithium-ion battery. The handpiece used by the practitioner consists of a cylindrical body of anodized aluminum which encloses the optics that transmit the laser energy to the disposable fiber tip or PBM adapters. The red aiming light is emitted directly from the aperture of the laser attached to the hand piece. Additionally, the handpiece illuminates the target work area with bright white LED lights during procedures through the translucent disposable tips. The wireless footswitch provides hands-free laser activation. The switch utilized high band Bluetooth technology to wirelessly control the initiation and termination of laser power from the laser aperture. Haptic feedback is also incorporated into the foot pedal to provide a vibration upon laser activation which can be adjusted from low to medium, or high, The single-use disposable fiber tip includes a translucent plastic tip body, stainless steel tube and a 400-micron polished optical fiber. The Gemini 2 810 + 980 Soft Tissue Laser was designed to utilize the same disposable tip as the Gemini 810+980 Soft Tissue Laser, previously cleared by FDA (K192617). The PBM adapters are accessory attachments for the Gemini 2 810 + 980 Soft Tissue Laser which expand the diameter of the laser beams spot size to 25mm, 3mm or 7mm. The lager diameter laser beam is used for Photobiomodulation indications such as pain management. The PBM adapters are designed to be held in a fixed location for the duration of the treatment. The 25mm adapter is only intended for extraoral use directly on intact skin and is designed at a diameter for larger work areas. Single-use disposable spacers are intended to be used with the 25mm adapter to limit the risk of cross contamination between patients. Due to the extraoral use, and disposable spacers, the 25mm PBM adapter is not to be steam sterilized. The 3mm and 7mm PBM tips are intended to be used intraorally and are designed at an I angle for reaching the back of the mouth. Steam sterilization and cleaning are required for both the 3mm and 7mm PBM adapters before each use. Non-clinical testing was conducted on the 3mm and 7mm adapters to test that the adapters increased the intra oral tissue temperature to the FDA quidelines for the ILY product code. The results showed that even in the intraoral environment, the efficacy of the adapters was met and showed substantial equivalence to the previously cleared device. In addition, non-clinical testing was also conducted with the use of an FDA cleared barrier sleeve over the 3mm and 7mm Intra Oral adapters. The results show that the use of the sleeve did not affect the efficacy of the product. The laser unit is controlled by a Main Control Unit (MCU) processor that is integrated into the main PCB. The PCB contains the software and hardware which requlates voltages and current and controls all the other functions and safety features. The PCB may be powered by either lithium-ion battery pack, or the included AC power supply. The PCB was designed to allow the power supply to provide power to the unit while simultaneously charging the battery pack. The Gemini 2 810+980 Soft Tissue Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. Additionally, custom presets and individual user settings are stored in memory to be adjusted by users at any time. During the development process, regulations are recognized and applies to meet requirements, potential hazards are evaluated and mitigated for the safety of the patient and/or the operator. The Gemini 2 810 + 980 Soft Tissue Laser has software features that allows for access to training videos, user manuals and software updates.

Dental Soft Tissue Indications Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - Fibroma removal - · Frenectomy - · Frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - · Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - · Implant recovery - Incision and drainage of abscess - · Leukoplakia - · Operculectomy - · Oral papillectomies - · Pulpotomy - Pulpotomy as an adjunct to root canal therapy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Treatment of aphthous ulcers. - · Vestibuloplasty - · Tissue retraction for impression - · Lesion (tumor) removal. Laser Periodontal Procedures. - · Laser soft tissue curettage. - · Laser removal of diseased, Inflamed and necrosed soft tissue within the periodontal pocket. · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. · Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - · Reduction of bacterial level (decontamination) and inflammation ## Pain therapy · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain, the temporary increase in local blood circulation; the temporary relaxation of muscle.

Gemini is an 810nm + 980nm soft tissue laser is intended for the incision, ablation, vaporization, hemostasis and treatment of oral soft tissue and for pain relief using photobiomodulation. The Gemini laser operates at a wavelength of 810nm +/- 10nm or at 980 +/- 10nm or a combination of both 810nm + 980nm wavelengths, with a maximum average power of 2 watts +/- 20% and maximum peak pulse power of 20 watts +/- 20% when in dual wavelength mode. The dual wavelength diode laser radiation is delivered through a flexible optical fiber and the Photobiomodulation (PBM) Adapter. Infrared laser energy is emitted from the fiber tips and the PBM Adapter when the wireless footswitch is depressed. The laser diodes are directly coupled to the flexible fiber optic able that connects the laser unit to the surgical hand piece and to the disposable fiber tip and PBM Adapter that emits the energy to the target area. The laser diodes can simultaneously emit energy when Gemini is set to dual wavelength mode. The Gemini unit comprises of six main assemblies: a Laser unit, a flexible fiber optic delivery svstem tethered to an anodized aluminum hand piece, disposable single-use fiber tips. PBM Adapter with spacers, a wireless footswitch, and an auxiliary power supply. The system also contains a 5mW 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser system is contained within a compact lightweight impact resistant molded plastic housing that contains a laser diode assembly, a laser power controller PCB, an Electroluminescent Display connected to an interface PCB, a touch sensitive selection panel with status lights, and a rechargeable Lithium Battery. The hand piece used by the practitioner consists of an anodized aluminum cylindrical body which encloses the optics used to transfer the laser energy to the single-use fiber tips and the PBM Adapter. The LED illumination system for lighting the work area will be off for PBM Adapter. The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber into the target tissue. Additionally, a bright white light from the LEDS in the hand piece illuminates target work area during procedures through the translucent disposable laser tips. The PBM Adapter is an accessory attachment to the Gemini laser system to increase the spot size of the laser beam, allowing the Gemini Laser to provide near-infrared laser energy to a tissue surface for the purpose of photobiomodulation. Affected muscles and/or joints must be exposed to an adequate level of laser energy over a period of time to provide effective results. The spot size of the PBM Adapter is 25 mm. The PBM Adapter operates at 810nm ± 10nm wavelength with a maximum average power of 1 watt ± 20%. A PBM spacer is attached to the PBM Adapter. The spacer is a single-use disposable piece designed to ensure proper working distance to target tissues and limit the risk of cross contamination between patients. The PBM Adapter is designed to only work with the Gemini Laser System. Gemini 810 + 980 Diode Laser utilizes non-volatile, preprogrammed firmware that cannot be modified by the user. During the development process, requirements are met, hazards are evaluated and mitiqated for the safety of the patient and /or the operator and the firmware. It does not capture any data related to patients. The Gemini software focuses on the functional and technical design for the Gemini laser. This includes the graphical user interface (GUI), the control of the laser drivers, sound, tip illumination and aiming light.

The ELUMI 810+980 Soft Tissue Laser is intended for the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue. The following are the oropharyngeal indications for use: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - Fibroma removal - · Gingivoplasty - · Hemostasis and coagulation - · Incision and drainage of abscess - · Operculectomy - · Pulpotomy - · Reduction of gingival hypertrophy - · Soft tissue crown lengthening - · Vestibuloplasty - · Laser Soft Tissue Curettage - · Tissue retraction - Frenectomy and Frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - · Gingival incision and excision - · Implant recovery - · Leukoplakia - · Oral papillectomnies - Pulpotomy as an adjunct to root canal therapy - · Reduction of bacterial level (decontamination) and inflammation - Treatment of aphthous ulcers - · Lesion (tumor) removal - · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - · Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium · Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - · Light activation for bleaching materials for teeth whitening - · Laser-assisted whitening/bleaching of teeth

The ELUMI 810 + 980 Soft Tissue Laser, or ELUMI, is a battery-powered counter top surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental teeth whitening. The ELUMI comprises of five main assemblies; of a Laser Unit, a flexible fiber delivery system tethered to an anodized aluminum hand piece, disposable single-use fiber tips, a wireless footswitch, and an auxiliary power supply. Infrared laser energy is emitted from the fiber tips when the wireless footswitch is depressed. The ELUMI Laser Unit contains two single-emitter solid-state laser diodes of 10.0-watt peak output power each (Class IV laser), one lasing at 810nm and the other at 980nm wavelength. The laser diodes can simultaneously emit laser energy when ELUMI is set to Dual Wavelength mode. The laser diodes are directly coupled to the flexible fiber optic cable that connects the Laser Unit to the surgical hand piece and disposable fiber tip that emits the energy to the target area. The system also contains a 5mW power, 650nm laser diode coupled to the same fiber optic cable to produce the red aiming light. The laser's visible light is designed to aid the clinician in aiming the tip of the delivery fiber onto the target tissue. Additionally, a bright white light from two LEDs in the hand piece illuminates tarqet tissue during procedures through the translucent disposable laser tips. The auxiliary power supply connects to the Laser Unit and is used to charge the system battery and as a power source for the system in the event of low battery capacity.