Search Results

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity prevention - Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity - Cutting, shaving, contouring and resection of oral osseous tissue (both) - Aiding in the reduction of mineral loss in dental enamel

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um. The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity preparation - Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity - Cutting, shaving, contouring and resection of oral osseous tissue (bone)

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494) and hard tissue indications (K130420). The only changes from the previously cleared device are the addition of the osseous tissue indications. There have been no software changes or graphic changes to the Solea system. The osseous tissue settings are the same as the previously cleared device (K130420). The osseous settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494 and K130420. The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity preparation. - Incision, Excision, Vaporization, Coagulation and Hemostasis of soft tissue in the oral cavity.

The Solea system is a dental laser device previously cleared by the FDA for soft tissue dental indications (K123494). The only changes from the previously cleared device are the addition of the hard tissue indications, which combines minor software and graphic changes that will be added to the Solea system. This software change does not change the operational software, but adds a material selection icon on the home screen to include enamel, dentin, and soft tissue. The enamel and dentin settings have substantially equivalent fluence and irradiation as the hard tissue predicate devices. There are no other hardware or software changes to the Solea system device pending herein when compared to the device cleared under K123494. The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut and ablate hard tissue and to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25pm to safely and effectively perform ablation, incision, excision, vaporization, coagulation and hemostasis procedures.

The Solea system is indicated for the following: - Incision . - . Excision - . Vaporization - . Coagulation - Hemostasis . of soft tissue in the oral cavity.

The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy to cut soft tissue in the oral cavity. The Solea system utilizes advanced CO2 laser technology with a wavelength of 9.25μm to safely and effectively perform incision, excision, vaporization, coagulation, and hemostasis.