Engine, Trephine, Accessories, Ac-Powered
FDA product code HRG · Class I (low risk) · 21 CFR 886.4070 · Ophthalmic
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013151 | Asmotom Automated Trephine SystemHRG · Traditional | Bkg Opthalmics USA, Inc. | 12/14/2001SE |
| K981063 | Automated Corneal TrephineHRG · Traditional | Laser Center Dev. Corp. | 06/23/1998SE |
| K843957 | Ultrathin/Sp LensHRG · Traditional | Optical Systems Intl., Inc. | 07/31/1985SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | Scanlan Intl., Inc. | 06/05/1984SE |
| K823901 | Trephine Blades-Various ModelsHRG · Traditional | Edward Weck, Inc. | 01/17/1983SE |
| K791763 | (Micro-Keratron, Micro Duct Trephine)HRG · Traditional | Intl. Ophthalmic Industries Corp. | 11/05/1979SE |