The following data is part of a premarket notification filed by Optonol, Ltd with the FDA for Ex-press Minature Glaucoma Implant, Models R-20, R-30, R-50, Sts Versions.
| Device ID | K012852 |
| 510k Number | K012852 |
| Device Name: | EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS |
| Classification | Implant, Eye Valve |
| Applicant | OPTONOL, LTD 12300 TWINBROOK PKWY, STE 625 Rockville, MD 20852 |
| Contact | Richard E Lippman |
| Correspondent | Richard E Lippman OPTONOL, LTD 12300 TWINBROOK PKWY, STE 625 Rockville, MD 20852 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-24 |
| Decision Date | 2002-03-26 |
| Summary: | summary |