Data / Medical devices / Germany / Leisegang Feinmechanik-Optik GMBH
Leisegang Feinmechanik-Optik GMBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Leisegang Feinmechanik-Optik GMBH is registered with the FDA (registration 9611604) in Berlin, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 23, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9611604
- FEI number
- 3002807462
- Address
- Leibnizstrasse 32, Berlin, Germany, D-10625
- Owner or operator
- COOPERSURGICAL, INC. (9002384)
- Roles
- Manufacturer
- First device listed
- December 13, 2022
- Registered through
- 2026
- Brand names listed
- Leisegang Colposcopes, OPTIK1-00, OPTIK1-01, OPTIK1-02, OPTIK1-03, OPTIK2-03, OPTIK2-03-002, OPTIK2-04 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 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 |
|---|---|---|---|---|---|---|
| October 23, 2014 | K140754 | COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM | HEX | Substantially Equivalent | CooperSurgical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 23, 2014. 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.