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The RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatology, Dermand General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

1064 nm wavelength:

Tattoo Removal: Dark Ink: (Black & Blue)

Nevus of Ota

Removal or lightening of unwanted hair with or without adjuvant preparation.

Skin resurfacing procedures for the treatment of acne scars and wrinkles

532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece):

Tattoo Removal: Light Ink (Red, Sky Blue, Green)

Treatment of Vascular Lesions including, but not limited to:

• port wine birthmarks
• . telangiectasias
• spidcr angioma
• . cherry angioma
• spider nevi

Treatment of Pigmented Lesions including, but not limited to:

• . cafe-au-lait birthmarks
• . solar lentiginos
• . senile lentiginos
• Becker's nevi
• Freckles
• Nevus spilus ◆

Skin resurfacing procedures for the treatment of acne scars and wrinkles

The RevLite System laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.

This 510(k) summary for the RevLite Q-Switched Nd: YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: none"

This means no studies were submitted to demonstrate performance against specific acceptance criteria. The clearance for this device was based on substantial equivalence to predicate devices (Focus Medical NaturaLase 1064 2 Joule Laser System and MedLite C6 Q-Switched Nd: YAG Laser System) in terms of "indications for use, technical specifications, operating performance features, and general design features," rather than new performance data.

Therefore, I cannot provide the requested information.

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