MOLTENO3
Implant, Eye Valve
IOP, INC.
The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Molteno3.
Pre-market Notification Details
| Device ID | K062252 |
| 510k Number | K062252 |
| Device Name: | MOLTENO3 |
| Classification | Implant, Eye Valve |
| Applicant | IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka IOP, INC. 3184 AIRWAY AVE., BLDG. B Costa Mesa, CA 92626 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-03 |
| Decision Date | 2006-09-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09419196000106 | K062252 | 000 |
| 09419196000090 | K062252 | 000 |
Trademark Results [MOLTENO3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOLTENO3 78682325 3277087 Dead/Cancelled |
Molteno, Anthony Christopher Bernard 2005-07-31 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.