3M Corneal System (Corneal Preservation Medium)
FDA 510(k) K863129 · 3M Company
510(k) numberK863129
Submission
- Device name
- 3M Corneal System (Corneal Preservation Medium)
- Applicant
- 3M Company
St. Paul, MN, US - Received
- August 15, 1986
- Decision date
- September 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LYX – Media, Corneal Storage
- Device class
- Unclassified
Other 510(k)s with product code LYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251320 | XTRA4LYX · Traditional | Al.Chi.Mi.A. S.R.L | 09/11/2025SE |
| K221759 | CornisolLYX · Traditional | Aurolab | 10/05/2022SE |
| K211786 | Independent Corneal Viewing Chamber (IVC-21)LYX · Traditional | Bausch + Lomb, Incorporated | 12/03/2021SE |
| K162013 | Eusol-CLYX · Special | Al.Chi.Mi.A. S.R.L | 09/15/2016SE |
| K151061 | Cornea ColdLYX · Traditional | Eurobio | 08/06/2015SE |
| K063304 | LIFE4CLYX · Traditional | Numedis, Inc. | 12/21/2007SE |
| K063617 | Eusol-CLYX · Special | Al.Chi.Mi.A | 02/08/2007SE |
| K032422 | Eusol-CLYX · Traditional | Al.Chi.Mi.A | 12/15/2003SE |
| K954548 | The Chen MediumLYX · Traditional | Chen Ophthalmic Laboratories | 05/20/1996SE |
| K924165 | Optisol-Gs Corneal Storage MediaLYX · Traditional | Chiron Intraoptics | 10/06/1992SE |
More from Chiron Intraoptics
| 510(k) | Device | Decision |
|---|---|---|
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 01/28/2025SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Corneal System (Corneal Preservation Medium) cleared by the FDA?
3M Corneal System (Corneal Preservation Medium) (K863129) received a 510(k) decision of Substantially Equivalent on September 17, 1986, 33 days after the submission was received.
What is the product code of K863129?
The FDA product code is LYX – Media, Corneal Storage, a Unclassified device.