FDA Product Code
FDA Product Code MXK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1850
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251848 | Pentacam® Cornea OCT | Oculus Optikgeräte GmbH | 2026-03-13 | Traditional | PDF ↗ |
| K252348 | Tomey Optical Biometer OA-2000 (OA-2000) | Tomey Corporation | 2025-12-18 | Traditional | PDF ↗ |
| K223700 | BOSS | Intelon Optics, Inc. | 2024-08-16 | Traditional | PDF ↗ |
| K222933 | MYAH | Visia Imaging S.R.L. | 2023-06-29 | Traditional | PDF ↗ |
| K211868 | MYAH | Visia Imaging S.R.L. | 2022-03-01 | Traditional | PDF ↗ |
| K202989 | Myopia Master | Oculus Optikgeräte GmbH | 2021-07-14 | Traditional | PDF ↗ |
| K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020-10-21 | Traditional | PDF ↗ |
| K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019-07-25 | Traditional | PDF ↗ |
| K191051 | ARGOS | Santec Corporation | 2019-05-16 | Traditional | PDF ↗ |
| K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016-01-20 | Traditional | PDF ↗ |
| K150754 | ARGOS | Santec Corporation | 2015-10-02 | Traditional | PDF ↗ |
| K073508 | PARKONE | Oculus Optikgerate GmbH | 2008-09-11 | Traditional | PDF ↗ |
| K071183 | ALLEGRO OCULYZER | Wavelight AG | 2007-07-20 | Traditional | PDF ↗ |
| K052935 | HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT) | Heidelberg Engineering | 2006-01-13 | Traditional | PDF ↗ |
| K051940 | CM 3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA | Sis Ltd., Surgical Instrument Systems | 2005-09-28 | Traditional | PDF ↗ |
| K041841 | PACHYCAM | Oculus Optikgerate GmbH | 2005-01-28 | Traditional | PDF ↗ |
| K042742 | HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) | Heidelberg Engineering | 2004-10-13 | Traditional | PDF ↗ |
| K031788 | PATHFINDER | Massie Research Laboratories, Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K040913 | NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) | Bausch & Lomb | 2004-07-23 | Traditional | PDF ↗ |
| K030393 | OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER | Haag-Streit Holding AG | 2003-09-25 | Traditional | PDF ↗ |
| K030719 | PENTACAM SCHEIMPFLUG CAMERA | Oculus Optikgerate GmbH | 2003-09-16 | Traditional | PDF ↗ |
| K991284 | ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM | Nidek, Inc. | 1999-08-06 | Traditional | PDF ↗ |
| K984443 | ORBSCAN | Technolas Perfect Vision GmbH | 1999-03-05 | Traditional | PDF ↗ |
Product code MXK · Class II · Ophthalmic. Data: openFDA.