Panels › Ophthalmic › Product code OOE · Class 2
Ophthalmic Femtosecond Laser
Regulation 886.4390
0510(k)s in 12 months (47 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in OOE
| Company | 510(k)s | Recalls |
|---|---|---|
| Lensar, Inc. | 13 | 0 |
| Technolas Perfect Vision GmbH | 9 | 0 |
| Amo Manufacturing USA, LLC | 5 | 1 |
| Optimedica Corporation | 4 | 2 |
| Alcon Laboratories, Inc. | 5 | 0 |
| Lensx Lasers, Inc. | 4 | 0 |
| Sie Ag,Surgical Instrument Engineering | 2 | 1 |
| Abbott Medical Optics, Inc. | 1 | 1 |
| Alcon Lensx, Inc. | 1 | 1 |
| Johnson & Johnson Surgical Vision, Inc. | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2021 | AMO Manufacturing USA, LLC Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 Open, Classified |
OOE | K113479 |
| May 9, 2018 | Johnson & Johnson Surgical Vision Inc OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33
Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMe Terminated |
OOE | K113479 K121091 +3 |
| Jan 21, 2018 | SIE AG, Surgical Instrument Engineering The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use Terminated |
OOE | K150323 |
| Apr 14, 2016 | Alcon Research, Ltd. LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery. Terminated |
OOE | K120732 |
| May 28, 2015 | Optimedica Corporation Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05
The OptiMedica Catalys Precision Laser System is indicated for use in patients und Terminated |
OOE | K141079 |
| Apr 23, 2015 | Abbott Medical Optics, Inc. OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US).
Product Usage:
Indicated for use in patients undergoing cataract surgery for removal of crystallin Terminated |
OOE | K141079 |
| Apr 9, 2014 | Alcon LenSx, Inc. Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Terminated |
OOE | None listed |
| Jan 8, 2014 | Optimedica Corporation Catalys Precision Laser System (United States) - Catalys-U:
Catalys Precision Laser System (International) - Catalys I
200-240V ~, 50/60 Hz, 15A,
(2) 15A Resettable CB:
Tested and complies with FCC P Terminated |
OOE | K121091 |
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