510(k) K894162
- Device
- OPTISOL
- Applicant
- CHIRON OPHTHALMICS
- 510(k) number
- K894162
- Product code
- LYX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-01-12
- Date received
- 1989-06-14
- Regulation
- 510(k) Premarket Notification
- Classification name
- Media, Corneal Storage
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MCGARVEY
- Address
- 9342 Jeronimo Rd. Irvine CA US 92718 92718
FDA Registration Numbers#
- 9710098
- 1920664
- 2027189
- 1047843
- 1526711
- 3004471819
- 1313525
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LYX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251320 | XTRA4 | Al.Chi.Mi.A. S.R.L | 2025-09-11 |
| K221759 | Cornisol | Aurolab | 2022-10-05 |
| K211786 | Independent Corneal Viewing Chamber (IVC-21) | Bausch + Lomb, Incorporated | 2021-12-03 |
| K162013 | Eusol-C | Al.Chi.Mi.A. S.R.L | 2016-09-15 |
| K151061 | Cornea Cold | Eurobio | 2015-08-06 |
| K063304 | LIFE4C | Numedis, Inc. | 2007-12-21 |
| K063617 | EUSOL-C | Al.Chi.Mi.A | 2007-02-08 |
| K032422 | EUSOL-C | Al.Chi.Mi.A | 2003-12-15 |
| K954548 | THE CHEN MEDIUM | Chen Ophthalmic Laboratories | 1996-05-20 |
| K924165 | OPTISOL-GS CORNEAL STORAGE MEDIA | Chiron Intraoptics | 1992-10-06 |
| K921728 | DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED | Chiron Intraoptics | 1992-06-09 |
| K921729 | OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED | Chiron Intraoptics | 1992-06-09 |
| K883854 | DEXSOL | Northern Scientific, Inc. | 1988-11-16 |
| K870249 | MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Bioclinical Laboratory Services, Inc. | 1987-04-06 |
| K870250 | MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM | Bioclinical Laboratory Services, Inc. | 1987-04-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases