Product code LOI
- Device name
- Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990078 | HYPERION LTK SYSTEM | Sunrise Technologies, Inc. | 2000-06-30 |
| P840012S007 | LASAG MICRORUPTOR III Q-SWITCH ND:YAG | Meridian AG | 1991-04-05 |
| P840012S006 | LASAG TOPAZ ND:YAG LASER SYSTEM | Meridian AG | 1990-05-01 |
| P830062S016 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1990-03-13 |
| P830062S015 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1989-09-08 |
| P830062S014 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1989-08-30 |
| P830054S022 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1989-08-29 |
| P850083S008 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1989-08-02 |
| P840012S005 | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM | Meridian AG | 1988-10-26 |
| P830054S021 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1988-08-30 |
| P830062S012 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1988-07-28 |
| P850083S007 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1988-07-15 |
| P830054S020 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1987-12-01 |
| P850001S009 | HORIZON(TM) YAG LASER MODEL 2000 | CooperVision, Inc. | 1987-10-27 |
| P850083S006 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1987-10-05 |
| P850083S005 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1987-09-30 |
| P840012S003 | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM | Meridian AG | 1987-08-27 |
| P830054S019 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1987-07-21 |
| P840012S002 | MICRORUPTOR MR-2 ND:YAG LASER SYSTEM | Meridian AG | 1987-06-22 |
| P830062S011 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1987-06-11 |
| P830054S018 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1987-05-19 |
| P850091 | YAGMASTER ND:YAG OP LASER | Bausch & Lomb, Inc. | 1987-04-30 |
| P850001S007 | HORIZON(TM) YAG LASER MODEL 2000 | CooperVision, Inc. | 1987-04-20 |
| P830062S009 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 | Nidek, Inc. | 1987-04-08 |
| P850083S004 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1987-03-31 |
| P830054S017 | NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 | Coherent Medical Division | 1987-03-31 |
| P850083S001 | VISULAS ND:YAG LASER | Carl Zeiss, Inc. | 1987-03-10 |
| P830080 | PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER | Synemed, Inc. | 1987-02-17 |
| P850019S002 | PHOTOTOME(TM) SYSTEM 2700 | Laser Media | 1987-01-09 |
| P840047S002 | CILCO ND:YAG LASER | Coopervision-Cilco | 1987-01-09 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881459 | NANOLAS ND:YAG OPHTHALMIC LASER | Biophysic Medical, Inc. | 1988-04-13 |