3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
FDA 510(k) clearance K863129 · decided 1986-09-17
Clearance details
- K-number
- K863129
- Device name
- 3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1986-08-15
- Decision date
- 1986-09-17
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- LYX
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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| XTRA4 (K251320) | Al.Chi.Mi.A. S.R.L | 2025-09-11 |
| Cornisol (K221759) | Aurolab | 2022-10-05 |
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| Eusol-C (K162013) | Al.Chi.Mi.A. S.R.L | 2016-09-15 |
| Cornea Cold (K151061) | Eurobio | 2015-08-06 |
| LIFE4C (K063304) | Numedis, Inc. | 2007-12-21 |
| EUSOL-C (K063617) | Al.Chi.Mi.A | 2007-02-08 |
| EUSOL-C (K032422) | Al.Chi.Mi.A | 2003-12-15 |
| THE CHEN MEDIUM (K954548) | Chen Ophthalmic Laboratories | 1996-05-20 |
| OPTISOL-GS CORNEAL STORAGE MEDIA (K924165) | Chiron Intraoptics | 1992-10-06 |
| OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (K921729) | Chiron Intraoptics | 1992-06-09 |
| DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (K921728) | Chiron Intraoptics | 1992-06-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |