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510(k) Data Aggregation
(87 days)
The Q-Switched Nd: YAG Laser machine is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm:
- Tattoo Removal
Dark ink: blue and black. - Treatment of Benign Pigmented Lesions
Nevus of ota.
532nm:
- Tattoo Removal
Light ink: red, Light ink: sky blue and green. - Treatment of Benign Vascular Lesions
Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. - Treatment of Benign Pigmented Lesions
Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
The Q-Switched Nd: YAG Laser machine is a laser system which delivers light at a wavelength 1064nm or 532nm. The Q-Switched Nd: YAG Laser machine is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology. The device comprises a main unit, light guide arm and footswitch.
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