LENSTAR, MODEL LS900— 510(k) K082891

Substantially Equivalent

Haag-Streit AG

FDA 510(k) clearance K082891 for LENSTAR, MODEL LS900, Substantially Equivalent on 2009-10-20. Applicant: Haag-Streit AG. Device class: 2.

Clearance details

Applicant: Haag-Streit AG
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2008-09-30
Decision date: 2009-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wadsworth, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K082891

K-number listed on FDA's recall record

Z-1560-2021 — Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.Class II·Ongoing·Haag-Streit USA Inc·20210415

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082891.

Data sourced from openFDA. This site is unofficial and independent of the FDA.