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The 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for: Tattoo removal Red inks (532 nm Hand Piece Adapter) Blue and light blue inks (Yellow Dye Pack) Green inks (Red Dye Pack) Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter Port wine birthmark Telangiectasias Spider angiomas Cherry angiomas Spider nevi Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter Café-au-lait birthmarks Solar lentigines Senile lentigines Becker's nevi Freckles Nevus spilus Nevus of ota Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.

The Focus Medical 532 Hand Piece Adapter and the Dye Pack Accessory are accessories to the NaturaLase 1064 O-Switched laser. The 532 Hand Piece Adapter converts the 1064 nm laser energy of the NaturaLase to 532 nm laser energy. The Red Dye Pack Accessory converts the 532 nm laser energy to a red beam (595-660 nm) and the Yellow Dye Pack Accessory converts the 532 nm laser energy to a yellow beam (568 - 590 nm).

The provided text states: "Performance Data: None required. The claim of substantial equivalence is based on comparisons of specifications, characteristics, and indications for use of the claimed predicates."

Therefore, based on the input document, no specific acceptance criteria or study data demonstrating the device meets such criteria are provided. The device's submission relied on substantial equivalence to predicate devices rather than direct performance data.

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