Cleared Traditional

PSL CLASSIC SLIT LAMP

K100500 · Keeler Instruments, Inc. · Ophthalmic
Mar 2010
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K100500 is an FDA 510(k) clearance for the PSL CLASSIC SLIT LAMP, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on March 9, 2010, 15 days after receiving the submission on February 22, 2010. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K100500 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2010
Decision Date March 09, 2010
Days to Decision 15 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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