Data / Medical devices / United States / Novian Health Inc.
Novian Health Inc.: FDA-registered device maker in Chicago, IL, United States, 2 510(k) clearances
Novian Health Inc. is registered with the FDA (registration 3009383334) in Chicago, IL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 26, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009383334
- Address
- 222 Merchandise Mart Plz Ste 228, Chicago, IL, United States, 60654
- Owner or operator
- Novian Health (10039185)
- Roles
- Specification developer
- First device listed
- December 15, 2011
- Registered through
- 2026
- Brand names listed
- Novilase
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 26, 2016 | K160392 | Novilase Laser Therapy System, Model LTS-2 | GEX | Substantially Equivalent | Novian Health, Inc. | accessdata.fda.gov |
| May 2, 2007 | K070353 | KELSEY INTERSITITAL LASER THERAPY SYSTEM | GEX | Substantially Equivalent | Kelsey, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 26, 2016. 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.