RegWardenFDA facility compliance records
Facility

LAP GMBH LASER APPLIKATIONEN

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

Activity 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)

Devices registered here (1)

  • Instrument, Quality-Assurance, Radiologic
    Product code LHO (opens in a new tab) · Class I · Radiology · 21 CFR 892.1940

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)

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LAP GMBH LASER APPLIKATIONEN (FEI 3000253133) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000253133-lap-gmbh-laser-applikationen/

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