The following data is part of a premarket notification filed by Innovative Ophthalmic Products, Inc. (iop) with the FDA for Molteno3 Glaucoma Implant.
| Device ID | K152996 |
| 510k Number | K152996 |
| Device Name: | Molteno3 Glaucoma Implant |
| Classification | Implant, Eye Valve |
| Applicant | INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) 3184-B AIRWAY AVE Costa Mesa, CA 92626 |
| Contact | Bryan Weinmann |
| Correspondent | James R Ravitz Arent Fox, LLP 1717 K Street, NW Washington, DC 20006 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2015-12-17 |
| Summary: | summary |