Data / Medical devices / United States / Lutech Industries
Lutech Industries: FDA-registered device maker in Indianapolis, IN, United States, 2 510(k) clearances
Lutech Industries is registered with the FDA (registration 3036423383) in Indianapolis, IN, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036423383
- Address
- 3910 Industrial Blvd, Indianapolis, IN, United States, 46254
- Owner or operator
- Waverly Life Sciences LLC (10092757)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- February 14, 2025
- Registered through
- 2026
- Brand names listed
- LT-300 HD, LT-300 SD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| May 21, 2017 | K170446 | LT-300 SD Digital Video Colposcope | HEX | Substantially Equivalent | Lutech Industries, Inc. | accessdata.fda.gov |
| May 13, 2016 | K160380 | LT-300 HD | HEX | Substantially Equivalent | Lutech Industries, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 21, 2017. 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.