Data / Medical devices / United States / Laser Engineering, Inc.
Laser Engineering, Inc.: FDA-registered device maker in Nashville, TN, United States, 1 510(k) clearance
Laser Engineering, Inc. is registered with the FDA (registration 1060848) in Nashville, TN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1060848
- FEI number
- 3000204219
- Address
- 475 Metroplex Dr Ste 401, Nashville, TN, United States, 37211
- Owner or operator
- Laser Engineering Inc (9022995)
- Roles
- Manufacturer
- First device listed
- March 2, 2023
- Registered through
- 2026
- Brand names listed
- Aurora MD30 Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | 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 |
|---|---|---|---|---|---|---|
| September 22, 2022 | K211605 | Dual Switch | GEX | Substantially Equivalent | Laser Engineering, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 22, 2022. 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.