Product code MXK
- Device name
- Device, Analysis, Anterior Segment
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1850
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026-03-13 |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 |
| K223700 | BOSS™ | Intelon Optics, Inc. | 2024-08-16 |
| K222933 | MYAH | Visia Imaging S.R.L. | 2023-06-29 |
| K211868 | MYAH | Visia Imaging S.R.L. | 2022-03-01 |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021-07-14 |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020-10-21 |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019-07-25 |
| K191051 | ARGOS | Santec Corporation | 2019-05-16 |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016-01-20 |
| K150754 | ARGOS | Santec Corporation | 2015-10-02 |
| K073508 | PARKONE | Oculus Optikgerate GmbH | 2008-09-11 |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | 2007-07-20 |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | 2006-01-13 |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | 2005-09-28 |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | 2005-01-28 |
| K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | Heidelberg Engineering | 2004-10-13 |
| K031788 | PATHFINDER | Massie Research Laboratories, Inc. | 2004-09-02 |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | 2004-07-23 |
| K030393 | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | Haag-Streit Holding AG | 2003-09-25 |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | Oculus Optikgerate GmbH | 2003-09-16 |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | Nidek, Inc. | 1999-08-06 |
| K984443 | ORBSCAN | Technolas Perfect Vision GmbH | 1999-03-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860003630624 | BOSS | Intelon Optics, Inc. | 2026-05-22 |
| 04049584034953 | Pentacam Cornea OCT | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2026-03-31 |
| 04571130283343 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | TOPCON CORPORATION | 2025-11-17 |
| 00380659984372 | WaveLight | Alcon Laboratories, Inc. | 2025-03-12 |
| 03664188000558 | ESSILOR | LUNEAU TECHNOLOGY OPERATIONS | 2025-01-02 |
| 03664188000565 | ESSILOR | LUNEAU TECHNOLOGY OPERATIONS | 2025-01-02 |
| 08034028770517 | ESSILOR | VISIA IMAGING SRL | 2024-11-04 |
| 08034028770487 | MYAH | VISIA IMAGING SRL | 2023-10-12 |
| 03664188000060 | Visionix | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000404 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000923 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000930 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 04059237000730 | HRT3 | Heidelberg Engineering GmbH | 2023-03-03 |
| 08034028770463 | MYOPIA EXPERT 700 | VISIA IMAGING SRL | 2022-06-22 |
| 08034028770456 | MYAH | VISIA IMAGING SRL | 2022-06-14 |
| 04049584025357 | Pentacam AXL Wave | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2021-11-03 |
| 04049584029942 | Myopia Master | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2021-11-03 |
| 04049584029959 | Myopia Master | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2021-11-03 |
| 04059237000747 | TOMOCAP | Heidelberg Engineering GmbH | 2020-10-29 |
| 03664188000039 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2020-05-25 |
| 03664188000909 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2020-05-25 |
| 03664188000046 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2020-05-25 |
| 07640167751242 | GALILEI | SIS AG, Surgical Instrument Systems | 2019-09-20 |
| 04573344510024 | OPTICAL BIOMETER | SANTEC CORPORATION | 2019-05-22 |
| 04059237000242 | SPECTRALIS, HRT3, HEP | Heidelberg Engineering GmbH | 2016-12-16 |
| 03664188002200 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2016-09-23 |
| 03664188001203 | VISIONIX | LUNEAU TECHNOLOGY OPERATIONS | 2016-09-23 |
| 04049584000217 | Park 1 | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2016-09-01 |
| 04049584000019 | Pentacam | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2016-09-01 |
| 04049584000026 | Pentacam HR | OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung | 2016-09-01 |