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The Diode laser device is intended for use in dermatology procedures requiring coagulation. The indications for use for the Trio-Wavelength Handpiece include: The Fast Hair Removal (FHR) Mode is intended for temporary hair reduction. The HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions. The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and FHR Modes).

The Diode Laser device includes two handles with different laser band characteristics. One handle contains a single-band 808nm semiconductor laser, and the other handle contains a three-band (755nm/808nm/1064nm) semiconductor laser. The semiconductor lasers of the two handles are powered by the laser power supply in the host to emit laser of corresponding wavelength. Working principle of semiconductor laser Semiconductor laser uses semiconductor materials of different doping types as laser working substance, uses natural cleavage surface to form resonant cavity for laser oscillation and amplification, and adds forward voltage to PN junction area of semiconductor laser to form particle number inversion of non-equilibrium carrier between conduction band and valence band of semiconductor substance. When a large number of electrons and holes in particle number inversion state are recombined, excess energy will be released, and these energies will be expressed in the form of photons, that is, laser is formed. Due to resonance amplification of cleavage surface resonant cavity, the stimulated feedback is amplified, so that laser can be directionally emitted and output from semiconductor laser. The Diode laser device consists of a main unit, a handheld, a foot switch and a power cord. Mode Description 1) Trio FHR Mode The Diode Laser device Trio-Wavelength module with FHR mode is intended for temporary hair reduction. In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation. 2) Trio HR Mode The Diode Laser device Trio-Wavelength module with HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the HR mode include: Benign vascular and vascular dependent lesions. In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation. 3) 810nm wavelength The 810nm wavelength handpiece is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI)including tanned skin. (HR, and FHR Modes) HR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 1-10 Hz and energy fluence is 2-60J/cm2. The operator can adjust the parameters within this range according to the actual situation. FHR Mode: In this mode, there is a set of parameter setting ranges. The specific parameter ranges are as follows: Frequency is 10 Hz and energy fluence is 2-8J/cm2. The operator can adjust the parameters within this range according to the actual situation. The FHR Mode of the two handpiece (810nm& Trio-Wavelength) is the fast hair removal mode. This mode means a quick option for pulse frequency. In the FHR mode, the frequency is fixed at 10Hz and cannot be adjusted. The FHR mode of the 810nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for temporary hair reduction. The HR mode of the two handpiece (810nm& Trio-Wavelength) is designed to differentiate from the FHR mode in terms of parameters. The HR mode covers all pulse frequency ranges (frequency: 1 - 10 Hz), and the pulse frequency can be adjusted. The HR mode of the 810 nm handpiece is used for permanent reduction in hair regrowth defined as a long term, while the FHR mode of the Trio -wavelength handpiece is used for benign vascular and vascular dependent lesions. 4) Operation Differences: In terms of user operation, the software has two operation modes: HR mode and FHR mode. After startup, there will be a selection interface for these two modes. Users can select different devices to enter different interfaces. In the HR mode interface, can adjust the frequency and energy fluence through the up and down buttons. In the FHR mode interface, the frequency cannot be adjusted, and only the energy fluence can be adjusted through the up and down buttons. Other operations are the same for both modes.

The Optimas MAX System with the Diolaze XL MAX is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. The Fusion Light and the Fusion Dark are intended for hair removal. The Optimas MAX System with the VasculazeMAX is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The Optimas MAX System with the Lumecca Peak Applicators are indicated for use for the following treatments: - The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, superficial leg veins and venous malformations. The Optimas MAX System with the Plus and Forma Handpieces are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation The Optimas MAX System with the he Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.

The Optimas MAX system is a computerized, versatile system that generates Laser, IPL, and RF energies for the treatment of several clinical indications. The device utilizes different applicators to achieve its mode of operation in accordance with the selected technology and clinical indication. The device system operates when any of the applicators are connected and enables individual adjustment of treatment parameters. The water-cooling system provides cooling for laser and IPL applicators and thermoelectric coolers (TECs). The cooling system includes a radiator, water pump, fan, water reservoir, deionizer, water filter, tissue contact temperature sensor, and water flow sensor. The system is compatible with the following applicators: - DIOLAZE XL 810, 810/1064 and 755/810 (previously cleared as DIOLAZE XL) - LUMECCA 515 PEAK and LUMECCA 580 PEAK (previously cleared as LUMECCA) - VASCULAZE 1064 (previously cleared as Vasculaze) - FORMA (previously cleared as Forma (Plus)) - PLUS (previously cleared as Plus/Plus) - MORPHEUS8 - MORPHEUS8 DEEP (previously cleared in K231790 as MORPHEUS8 Body)

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.