Product code LZS
- Device name
- Excimer Laser System
- 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
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P060004S011 | MEL 90 Excimer Laser | Carl Zeiss Meditec, Inc. | 2026-04-30 |
| P060004S009 | MEL 90 EXCIMER LASER SYSTEM | Carl Zeiss Meditec, Inc. | 2025-05-23 |
| P020050S043 | WaveLight EX500 Laser | Alcon Laboratories, Inc. | 2025-03-05 |
| P990027S025 | TENEO 317 Model 2 | Technolas Perfect Vision GmbH | 2025-02-06 |
| P990027S023 | TENEO 317 Model 2 | Technolas Perfect Vision GmbH | 2025-02-04 |
| P030008S039 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2025-01-16 |
| P020050S044 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2025-01-16 |
| P990027S024 | TENEO 317 Model 2 | Technolas Perfect Vision GmbH | 2024-12-16 |
| P060004S006 | MEL90 | Carl Zeiss Meditec, Inc. | 2024-12-04 |
| P990027S022 | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) | Technolas Perfect Vision GmbH | 2024-11-06 |
| P930016S067 | iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System | Amo Manufacturing USA, LLC | 2024-08-09 |
| P930016S065 | STAR S4 IR Excimer Laser | Amo Manufacturing USA, LLC | 2024-07-01 |
| P930016S066 | iDesign Refractive Studio | Amo Manufacturing USA, LLC | 2024-03-22 |
| P930016S064 | iDesign Refractive Studio (iDesign/G301) | Amo Manufacturing USA, LLC | 2024-03-21 |
| P060004S007 | MEL 80 Excimer Laser | Carl Zeiss Meditec, Inc. | 2024-03-13 |
| P030008S038 | WaveLight EX500 Laser | Alcon Laboratories, Inc. | 2024-02-15 |
| P020050S042 | WaveLight EX500 Laser | Alcon Laboratories, Inc. | 2024-02-15 |
| P990027S021 | TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System | Technolas Perfect Vision GmbH | 2023-11-22 |
| P930016S063 | iDesign Refractive Studio | Amo Manufacturing USA, LLC | 2023-10-16 |
| P030008S037 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2023-08-23 |
| P020050S041 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2023-08-23 |
| P030008S036 | WaveLight EX500 Laser System with Patient Bed Swivel 1125 | Alcon Laboratories, Inc. | 2023-06-02 |
| P020050S040 | WaveLight EX500 Laser System with Patient Bed Swivel 1125 | Alcon Laboratories, Inc. | 2023-06-02 |
| P060004S005 | MEL 80 Excimer Laser System | Carl Zeiss Meditec, Inc. | 2023-02-16 |
| P060004S004 | MEL 80 Excimer Laser System | Carl Zeiss Meditec, Inc. | 2023-02-16 |
| P030008S035 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2021-11-19 |
| P020050S039 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2021-11-19 |
| P030008S034 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2021-07-08 |
| P020050S038 | WaveLight EX500 Laser System | Alcon Laboratories, Inc. | 2021-07-08 |
| P930016S062 | iDesign Advanced WaveScan Studio, STAR Excimer Laser System | Amo Manufacturing USA, LLC | 2021-02-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380659984372 | WaveLight | Alcon Laboratories, Inc. | 2025-03-12 |
| 04049471095074 | MEL 90 | Carl Zeiss Meditec AG | 2024-12-13 |
| 04050555004202 | TECHNOLAS TENEO 317 | Technolas Perfect Vision GmbH | 2023-12-17 |
| 00380650001108 | WAVELIGHT REFRACTIVE SUITE | Alcon Laboratories, Inc. | 2021-02-24 |
| 05050474651449 | IDESIGN RS | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2018-08-21 |
| 05050474620278 | IDESIGN RS | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2018-08-21 |
| 05050474651456 | IDESIGN RS | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2018-08-15 |
| 05050474651432 | IDESIGN RS | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2018-08-15 |
| 00380659909634 | WaveLight | Alcon Laboratories, Inc. | 2017-09-13 |
| 04987669101346 | Final Fit | NIDEK CO.,LTD. | 2017-08-25 |
| 00380650004567 | WAVENET | Alcon Laboratories, Inc. | 2016-04-08 |
| 00380659908163 | WAVENET | Alcon Laboratories, Inc. | 2016-04-08 |
| 05050474591912 | IDESIGN ADVANCED WAVESCAN STUDIO | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2015-07-15 |
| 04987669100042 | Final Fit™ | NIDEK CO.,LTD. | 2014-12-17 |
| 05050474573413 | STAR S4 IR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2014-11-28 |
| 05050474573444 | WAVESCAN WAVEFRONT SYSTEM | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2014-11-20 |
| 05050474591905 | WAVESCAN OFFLINE PROGRAMMING MODULE | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2014-11-14 |
| 00380659906060 | WAVELIGHT REFRACTIVE SUITE | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380659907463 | WAVELIGHT REFRACTIVE SUITE | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380659907678 | WAVELIGHT ALLEGRO TOPOLYZER | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380659907944 | WAVELIGHT EX500 EXCIMER LASER | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380659908170 | WAVENET | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380659908965 | WAVELIGHT REFRACTIVE SUITE | Alcon Laboratories, Inc. | 2014-09-24 |
| 04987669100035 | Final Fit™ | NIDEK CO.,LTD. | 2014-09-15 |
| 04987669100028 | Quest™ | NIDEK CO.,LTD. | 2014-09-15 |
| 04987669100011 | NA | NIDEK CO.,LTD. | 2014-09-15 |
| 04049471000221 | MEL 80 | Carl Zeiss Meditec AG | 2014-09-03 |