The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Moa Bone / M-sphere.
| Device ID | K972143 |
| 510k Number | K972143 |
| Device Name: | MOA BONE / M-SPHERE |
| Classification | Implant, Eye Sphere |
| Applicant | IOP, INC. 3100 AIRWAY AVE., SUITE 106 Costa Mesa, CA 92626 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka IOP, INC. 3100 AIRWAY AVE., SUITE 106 Costa Mesa, CA 92626 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-10-16 |