Cleared Traditional

LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS

K122829 · Lensar, Inc. · Ophthalmic
Dec 2012
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K122829 is an FDA 510(k) clearance for the LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on December 3, 2012, 77 days after receiving the submission on September 17, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K122829 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2012
Decision Date December 03, 2012
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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