510(k) K213559
- Device
- FEMTO LDV Z8 Femtosecond Surgical Laser
- Applicant
- SIE AG, Surgical Instrument Engineering
- 510(k) number
- K213559
- Product code
- OOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-21
- Date received
- 2021-11-04
- Regulation
- 886.4390
- Classification name
- Ophthalmic Femtosecond Laser
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Frank Ziemer
- Address
- Allmendstrasse 11 Port CH CH-2502 CH-2502
FDA Registration Numbers#
- 3003288808
- 3023808060
- 1644019
- 3010208880
- 3007606649
- 2244478
- 1920664
- 1450662
- 3010160527
- 3006946276
- 3012236936
- 3006695864
- 1424263
- 2028159
- 1721676
- 3005173255
- 3004858034
- 2134604
- 3009298127
- 3003537036
- 1649518
- 9710340
- 3005675890
- 3009026057
- 1928237
- 3005012805
- 3009420598
- 1650907
- 3010291427
Source Documents#
Other 510(k) Records For Product Code OOE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025-04-28 |
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| K223838 | Catalys™ Precision Laser System | Amo Manufacturing USA, LLC | 2023-04-12 |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | 2022-06-09 |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | 2022-05-17 |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | 2021-04-07 |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2020-09-01 |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | 2020-05-18 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018-11-09 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-08-09 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018-03-27 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-03-02 |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017-10-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases