510(k) K082891 ยท HJO Biomicroscope, Slit-Lamp, Ac-Powered
LENSTAR, MODEL LS900
| Applicant | Haag-Streit AG, Wadsworth OH, US |
| Decision | Substantially Equivalent, Oct 20, 2009 |
| Received | Sep 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082891
| 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 | None listed |
| Aug 9, 2011 | Haag-Streit USA Inc Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System.
Haag-Streit USA, Inc.
A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Terminated |
HJB | None listed |
| Jun 24, 2010 | Haag-Streit USA Inc Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland.
Used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate pow Terminated |
HLF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.