FDA-Device2014-07-02Class II

LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

LAP of America Laser Applications, LLC
Hazard

While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.

Sold states
North Carolina
Affected count
1 system
Manufactured in
161 Commerce Rd Ste 3, N/A, Boynton Beach, FL, United States
Products
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1866-2014

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