FDA Registration
Active
🇺🇸 United States
MED-LOGICS, INC.
Reg #: 2085081
·
FEI: 1000142667
·
Expires 2026
Products
8
Proprietary Names
59
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- MED-LOGICS, INC.
- Registration Number
- 2085081
- FEI Number
- 1000142667
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1627 Enterprise St
- City
- Athens
- State
- TX
- ZIP
- 75751
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020079
Owner / Operator
- Firm Name
- MED-LOGICS, INC.
- Operator Number
- 9008330
- Address
- 1627 Enterprise Street, --
- City
- Athens
- State
- TX
- Postal Code
- 75751
- Country
- US
- Correspondent
- ROD - ROSS
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2012-12-06 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2011-10-12 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2001-02-22 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2012-12-06 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2022-04-15 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2014-01-20 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2001-02-22 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2001-02-22 |
Proprietary Names
ML7061 Calibrated LASIK Blade (CLB)
ML7050 Calibrated LASIK Blade (CLB)
ML9961D
ML7090 Calibrated LASIK Blade (CLB)
ML7003 Calibrated LASIK Blade (CLB)
ML7020 Calibrated LASIK Blade (CLB)
ML7040 Calibrated LASIK Blade (CLB)
2100ML7 ML7 Eye Marker
ML7061 Replacement Metal Head
ML7050 Metal Head
MLP6020 - Test Chamber (10PK) (53-0038-60)
MLP6016 - ST 45 Standard 45 Degree Tip (53-0064-60)
MLP6013 - SL 45 Slimline 45 Degree Tip (53-0072-60)
Sonic Wave Digital Phaco System
MLP6005 - Sonic Wave Phaco Handpiece
MLP6015 - ST 30 Standard 30 Degree Tip (53-0063-60)
MLP6012 - SL 30 Slimline 30 Degree Tip (53-0071-60)
MLP6019 - TW 45 Thinwall 45 Degree Tip (53-0075-60)
MLP6009 - IA Tip Curved (53-0023-60)
MLP6023 - Vitreous Cutter Infussion Sleeve (Nonsterile) (53-0048-60)
MLP6007 - Sonic Wave Remote Control
MLP6021 - Thinwall/Standard Silcone Sleeve (5PK) (53-0053-60)
MLP6008 - IA Handle Reverse (150-2020-511)
MLP6022 - Tip Wrench (Square Hole) (53-0037-60)
MLP6011 - SL 15 Slimline 15 Degree Tip (53-0070-60)
MLP6003 - Sonic Wave Vitreous Cutter
MLP6006 - Sonic Wave Foot Switch
MLP6001 - Sonic Wave Console
MLP6018 - TW 30 Thinwall 30 Degree Tip (53-0066-60)
MLP6017 - TW 15 Thinwall 15 Degree Tip (53-0065-60)
MLP6004 - Sonic Wave Vitreous Cutter (Disposable)
MLP6014 - ST 15 Standard 15 Degree Tip (53-0062-60)
D211666
MLP6002 - Sonic Wave Tubing
MLP6010 - Irrigation Set (Used with Vit Cutters)
MLP6024 - Drainage Bag
ML7030 Calibrated LASIK Blade (CLB)
1090ML7 - Ring, ML7, 9mm
1500ML7 - Sterilization Tray, ML7
1400ML7 - Handpiece, ML7
1100ML7 - 10mm
1300ML7 - Vacuum Handle, ML7
1095ML7 - Ring, ML7, 9.5mm
1350ML7 - Wrench, Helical Drive, ML7
1800ML7 - Footswitch, ML7
1700ML7 - Console, ML7
0130ML7 - Head, ML7, 130 Micron
1085ML7 - Ring, ML7, 8.5mm
1080ML7 - Ring, ML7, 8mm
0100ML7 - Head, ML7, 100 Micron
ML8060VS Vacuum Tubing
ML7 MICROKERATOME
ML7100 Calibrated LASIK Blade (CLB)
ML7070 Calibrated LASIK Blade (CLB)
ML8001VS Vacuum Tubing
ML110C CleanTouch PVA Eye Spear
ML100 CleanTouch PVA Eye Spear
ML110 CleanTouch PVA Eye Spear
ML115 CleanTouch PVA Wipe
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility