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The Quasar Calypso C100 is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of periorbital wrinkles. The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of periorbital wrinkles.

The Silver Bay, Quasar Calypso, C100 Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head containing the LED array and an on/off switch. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar Calypso C100 uses a 12 volt wall mount power supply. The C100 light delivery system used for applying therapy for the use in the treatment of periorbital wrinkles, by emitting at least 65 mW/cm² of red and near infrared (610nm to 850nm) light via an electic light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.

The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

The Silver Bay Quasar Calypso C50 is a visible light and/or heat source with high spectral purity. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light sources. The device is two-sided with one side emitting narrow band blue light at 405 to 420 nm. The opposite side of the device emits red light at 628 nm +- 10 nm. The device is operated by a momentary switch, which allows the operator to select either the blue or red operation. The device does not allow the operator to select the red and blue light simultaneously. The Quasar Calypso C50 uses a 12 volt wall mount power supply.

This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.

The "Quasar Blue" Blue Light Therapy System is intended to provide photo therapeutic light to the body. The "Quasar Blue" Blue Light Therapy System is generally indicated to treat dermatological conditions. The "Quasar Blue" Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris.

The "Quasar Blue" Blue Light Therapy System is identical to the company's previously cleared Quasar Blue Light Therapy System (K072767). Only the Operators Manual and the Patient Treatment Protocol have been modified to reflect the home use of the product. These documents have been amended to allow for an Over the Counter use. The Quasar Blue Light Therapy System has similar physical and technical characteristics to the predicate devices.

The Quasar Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Quasar Blue Light Therapy System is generally indicated to treat dermatological conditions. The Quasar Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

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