Panels › Ophthalmic › Product code HJO · Class 2
Biomicroscope, Slit-Lamp, Ac-Powered
Regulation 886.1850
2510(k)s in 12 months (109 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in HJO
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 9 | 6 |
| Bausch & Lomb, Inc. | 4 | 0 |
| Carl Zeiss, Inc. | 4 | 0 |
| Haag-Streit AG | 3 | 1 |
| R.H. Burton Co. | 4 | 0 |
| Keeler Limited | 3 | 0 |
| Kowa Co. , Ltd. | 3 | 0 |
| Kowa Optimed, Inc. | 3 | 0 |
| Nidek Co., Ltd. | 2 | 1 |
| Reichert, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 15, 2021 | Haag-Streit USA Inc Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. Open, Classified |
HJO | K082891 |
| Dec 7, 2020 | Carl Zeiss Meditec AG IOLMaster 700 Terminated |
HJO | K173771 |
| Jun 25, 2018 | Carl Zeiss Meditec AG Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany,
IOLMaster 700, REF 1932-169
SN 1185393
2017-09-01 Terminated |
HJO | K170171 |
| Jul 1, 2016 | Nidek Inc OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier.
Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the po Terminated |
HJO | K133132 |
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 500: Software versions 7.5 and 7.7;
Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white Terminated |
HJO | K101182 K122418 +1 |
| Dec 1, 2015 | Carl Zeiss Meditec AG IOL Master 5.5: Software versions 7.5 and 7.7;
Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation Terminated |
HJO | K101182 K122418 +1 |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Terminated |
HJO | K101182 K122418 +1 |
| Nov 15, 2013 | Carl Zeiss Meditec, Inc. Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered,
Product is manufactured by Carl Zeiss Meditec AG (Jena),
Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Ca Terminated |
HJO | K101182 K122418 +1 |
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