Data / Medical devices / United States / Med-Logics, Inc.
Med-Logics, Inc.: FDA-registered device maker in Athens, TX, United States, 11 510(k) clearances
Med-Logics, Inc. is registered with the FDA (registration 2085081) in Athens, TX, United States. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated January 13, 2004. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2085081
- FEI number
- 1000142667
- Address
- 1627 Enterprise St, Athens, TX, United States, 75751
- Owner or operator
- MED-LOGICS, INC. (9008330)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 22, 2001
- Registered through
- 2027
- Brand names listed
- 0100ML7 - Head, ML7, 100 Micron, 0130ML7 - Head, ML7, 130 Micron, 1080ML7 - Ring, ML7, 8mm, 1085ML7 - Ring, ML7, 8.5mm, 1090ML7 - Ring, ML7, 9mm, 1095ML7 - Ring, ML7, 9.5mm, 1100ML7 - 10mm, 1300ML7 - Vacuum Handle, ML7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Burr, Corneal, Manual | HOF | 1 | Manufacturer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Manufacturer | accessdata.fda.gov |
| Device, Irrigation, Ocular Surgery | KYG | 1 | Manufacturer | accessdata.fda.gov |
| Keratome, Ac-Powered | HNO | 1 | Manufacturer | accessdata.fda.gov |
| Marker, Ocular | HMR | 1 | Manufacturer | accessdata.fda.gov |
| Specula, Ophthalmic | HNC | 1 | Manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 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 |
|---|---|---|---|---|---|---|
| January 13, 2004 | K033293 | MED-LOGICS, MODEL ML7090 | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| November 15, 2002 | K022982 | MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| October 11, 2002 | K022716 | MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| April 19, 2002 | K020079 | BLADEWORKS MICROKERATOME BLADE, MODEL 7061 | HNO | Substantially Equivalent | Blade Works, Inc. | accessdata.fda.gov |
| June 22, 2001 | K010872 | ML BLADE, MODEL ML7030 | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| February 22, 2001 | K002515 | MEDLOGICS ML 4000, MODEL 4000 | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| August 18, 2000 | K002279 | ML EYE SPEAR, MODEL ML 27 ES | HOZ | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| March 20, 2000 | K993225 | BLADEWORKS MICROKERATOME BLADE | HNO | Substantially Equivalent | Blade Works, Inc. | accessdata.fda.gov |
| August 25, 1998 | K981989 | THE WAVE DIGITAL PHACO SYSTEM | HQC | Substantially Equivalent | Circuit Tree | accessdata.fda.gov |
| July 23, 1998 | K981071 | ML MICROKERATOME | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
| December 9, 1996 | K962661 | ML MICROKERATOME BLADE | HNO | Substantially Equivalent | Med-Logics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 13, 2015 | 70348 | Class II | Terminated | ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures. | The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder. | accessdata.fda.gov |
Compare with other makers
- All makers of Keratome, Ac-Powered
- All makers of Device, Irrigation, Ocular Surgery
- All makers of Burr, Corneal, Manual
- All makers of Cystotome
- All makers of Specula, Ophthalmic
- All makers of Marker, Ocular
Updated March 13, 2015. 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.