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The DT Controlled Phototherapy Equipment devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The DT Controller is a modernization of the DermaPal Controller (510(k) K073587). Like its predicate, the DT Controller is designed to turn a phototherapy device on and off based on time. It is designed to be installed in a wider family of devices. It uses the same 4 button UI with a larger backlit screen for better readability and is based on a more commercially available PIC16 processor. A modification to the way a prescription is entered was done to harmonize the process across different devices.

The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length). Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface. The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001. While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.

The 7 Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.

The 7 Series Phototherapy Equipment is a partial-body, ultraviolet light source emitting phototherapy panel. The physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. Its nominal size ranges from a 4 lamp no door; 74.5 In X 20 In X 24 In, 75 lbs (189.2 cm X 50.8 cm X 61 cm, 34 kg) to a 12 lamp with doors open; 74.5 In X 39.5 In X 24 In, 129 Lbs. (189.2 cm X 100.3 cm X 61 cm, 58.5 Kg) that is controlled by either an integrated digital timer with an LCD segmented display and four membrane buttons as the interface (the Flex Controller) or a microprocessor controller with an LCD touch screen display (the ClearLink Controller). When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light. The treatment area consists of 4, 6, 8, 10, or 12 100-watt lamps and reflective surfaces configured in a panel. The patient stands in front of the panel during treatment.

The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.

The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.

The ML24000 PC UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column. Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.

The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models: 3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24 M Series Models 311-10, 350-10, 311/350-04/06 The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source system, which is intended for use by or under the direction of a licensed physician for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema) on all skin types (I-VI).

The Smart Touch Multi Machine Software is used to control multi phototherapy devices from a custom built computer containing a UV3001 interface board supplied by Daavlin (schematics located in Device Specification of this 510(k) submission), with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). An "off the shelf" replacement is not possible. Replacement can ONLY be obtained by Daavlin. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema).

The 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light. The spectral output at peak wavelengths of 305nm,311nm,350nm,or 365nm depending on lamp. The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.

The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light. The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.

The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders. The 1-Series, equipped with PL-L36W /03 blue lamps, is indicated for the treatment of mild to moderate acne vulgaris

The 1 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light or blue light. The spectral output peaks at wavelengths of 305nm,311nm,350nm,365nm, or 420nm depending on lamp. The 1 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders or blue light radiation for acne vulgaris.