Data / Medical devices / United States / LAP of America Laser Applications, LLC.
LAP of America Laser Applications, LLC.: FDA-registered device maker in Boynton Beach, FL, United States, 1 510(k) clearance
LAP of America Laser Applications, LLC. is registered with the FDA (registration 1055485) in Boynton Beach, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 2018. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1055485
- FEI number
- 1000113153
- Address
- 161 Commerce Rd Ste 3, Boynton Beach, FL, United States, 33426
- Owner or operator
- LAP of America Laser Applications LLC (9019434)
- Roles
- Repackager or relabeler
- First device listed
- May 12, 2008
- Registered through
- 2026
- Brand names listed
- APOLLO, APOLLO MR3T, AQUARIUS, ARGO NAVIS, ASTOR, CARINAiso, CARINAnav, CARINAsim and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2018 | K173926 | DORADOnova MR3T | IYE | Substantially Equivalent | Lap GmbH Laser Applikationen | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 21, 2014 | 68259 | Class II | Terminated | 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. | 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. | accessdata.fda.gov |
| October 7, 2013 | 68266 | Class II | Terminated | CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment. | 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) | accessdata.fda.gov |
Compare with other makers
- All makers of Accelerator, Linear, Medical
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Monitor, Patient Position, Light-Beam
Updated September 14, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.