OPTICAL BIOMETER AL-SCAN— 510(k) K133132

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K133132 for OPTICAL BIOMETER AL-SCAN, Substantially Equivalent on 2014-06-11. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2013-09-30
Decision date: 2014-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K133132

K-number listed on FDA's recall record

Z-2587-2016 — 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 power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.Class II·Terminated·Nidek Inc·20160701

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133132.

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