LAP of America Laser Applications, LLC.
United Statesfrom the FDA registration address FDA establishment FEI 1000113153
- Devices
- 0
- Registrations
- FDA
- FDA recalls
- 2
Company details
- FDA FEI number
- 1000113153
- Address
- 161 Commerce Rd Ste 3, Boynton Beach, FL, 33426
FDA recalls
2014
- 21 Mar 2014 Z-1866-2014 Class II Terminated 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.
2013
- 7 Oct 2013 Z-1709-2014 Class II Terminated Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)
Full distribution text
- 7 Oct 2013 Z-1709-2014 Class II Terminated Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)