Molteno3 Glaucoma Implant— 510(k) K152996
Substantially EquivalentInnovative Ophthalmic Products, Inc. (Iop)
FDA 510(k) clearance K152996 for Molteno3 Glaucoma Implant, Substantially Equivalent on 2015-12-17. Applicant: Innovative Ophthalmic Products, Inc. (Iop).
Clearance details
- Applicant
- Innovative Ophthalmic Products, Inc. (Iop)
- Product code
- Code KYF
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
Adverse events under product code KYF
product code KYF- Injury
- 1,543
- Malfunction
- 646
- Total
- 2,189
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.