Aberrometer, Ophthalmic
FDA product code NCF · Class I (low risk) · 21 CFR 886.1760 · Ophthalmic
4510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062930 | Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | Alcon Research, Ltd. | 11/08/2006SE |
| K050336 | Opd-Station SoftwareNCF · Traditional | Nidek, Inc. | 08/24/2005SE |
| K023249 | Alcon Ladarwave Customcornea Wavefront SystemNCF · Abbreviated | Alcon Laboratories, Inc. | 10/18/2002SE |
| K000637 | Customcornea Measurement Device (CCMD)NCF · Traditional | Alcon Laboratories, Inc. | 05/19/2000SESU |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3050-2017 Class II | ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens…Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This… | Alcon Research, Ltd. | 06/30/2017Terminated |
| Z-3049-2017 Class II | ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular…Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This… | Alcon Research, Ltd. | 06/30/2017Terminated |