RegWardenFDA facility compliance records
Company

LAP of America Laser Applications LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls1’131’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2014-03-21
    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.
  • Class IITerminated2013-10-07
    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)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “LAP of America Laser Applications LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9019434-lap-of-america-laser-applications-llc/

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