Medical Laser Products
Definition: Ophthalmic Femtosecond Laser Intended To Provide Refractive Vision Correction By Modification Of The Shape Of The Cornea.
Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]
| Radiation Type | Optical |
| Radition Safety | Product |
| Annual Reports | Yes |
| 4451 | Femtosecond Laser System For Refractive Correction |
| 4451 | Femtosecond Laser System For Refractive Correction |
| P150040 | VisuMax Femtosecond Laser System | Carl Zeiss Meditec, Inc. |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2020-02-20 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2019-07-12 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2019-06-27 |
| RE-LEX SMILE | CARL ZEISS MEDITEC AG (JENA) | 2019-05-07 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2019-03-14 |
| RELEX SMILE | UNKNOWN | 2019-03-07 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2018-12-21 |
| VISUMAX FEMTOSECOND LASER | CARL ZEISS MEDITEC AG (JENA) | 2018-12-07 |
| VISUMAX FEMTOSECOND LASER (SMILE) | CARL ZEISS MEDITEC AG (JENA) | 2018-11-26 |
| VISUMAX FEMTOSECOND LASER (SMILE) | CARL ZEISS MEDITEC AG (JENA) | 2018-11-26 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2018-11-01 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2018-10-28 |
| ZEISS LASER | CARL ZEISS MEDITEC INC. | 2018-09-18 |
| SMILE | CARL ZEISS MEDITEC AG | 2018-09-17 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2018-09-11 |
| FEMTOSECOND LASER (SMILE) | CARL ZEISS MEDITEC | 2018-07-31 |
| RELEX SMILE | CARL ZEISS | 2018-05-09 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2018-01-18 |
| OPHTHALMIC FEMTOSECOND LASER | UNK | 2018-01-16 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-11-03 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-11-03 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-08-23 |
| RELEX SMILE APPARATUS | UNK | 2017-08-09 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-07-28 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-06-15 |
| VISUMAX FEMTOSECOND LASER | CARL ZEISS MEDITEC, INC. | 2017-04-06 |
| VISUMAX LASER KERATOME | CARL ZEISS MEDITEC AG (JENA) | 2017-03-11 |
| VISUMAX FEMTOSECOND LASER | CARL ZEISS | 2016-10-12 |