Data / Medical devices / Germany / Lap GMBH Laser Applikationen
Lap GMBH Laser Applikationen: FDA-registered device maker in LUENEBURG Lower Saxony, Germany, 2 510(k) clearances
Lap GMBH Laser Applikationen is registered with the FDA (registration 9681134) in LUENEBURG Lower Saxony, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9681134
- FEI number
- 3000253133
- Address
- Zeppelinstrasse 23, LUENEBURG Lower Saxony, Germany, D-21337
- Owner or operator
- LAP of America Laser Applications LLC (9019434)
- Roles
- Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Patient Position, Light-Beam | IWE | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 29, 2024 | K232031 | LUNA 3D | IYE | Substantially Equivalent | Lap GmbH Laser Applikationen | accessdata.fda.gov |
| September 14, 2018 | K173926 | DORADOnova MR3T | IYE | Substantially Equivalent | Lap GmbH Laser Applikationen | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Patient Position, Light-Beam
- All makers of Accelerator, Linear, Medical
- All makers of Instrument, Quality-Assurance, Radiologic
Updated March 29, 2024. 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.