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The RevLite O-switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and 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:

• . Prot wine birthmarks
• Telangiectasias .
• Spider angioma .
• Cherry angioma .
• Spider nevi .

Treatment of Pigmented Lesions including, but not limited to:

• Café-au-lait bithmarks .
• Solar lentiginos .
• Senile lentiginos .
• Becker's nevi .
• Freckles .
• Nevus spilus .

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

The RevLite System with LCD Panel 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.

The provided K063834 RevLite Q-Switched Laser System did not include any clinical performance data or studies. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: none".

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent questions related to a study, as no such study is described in this document.

The FDA's decision was based on a comparison to an equivalent device (RevLite C6 Q-Switched Nd: YAG Laser System - K063112) in terms of indications for use, technical specifications, operating performance features, and general design features, rather than on new performance data for this specific submission.

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