Cleared Traditional

CATARACT LIQUEFRACTURE DEVICE

K980292 · Alcon Laboratories · Ophthalmic
May 1998
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K980292 is an FDA 510(k) clearance for the CATARACT LIQUEFRACTURE DEVICE, a Fluidic, Phacoemulsification/phacofragmentation (Class II — Special Controls, product code MUS), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on May 19, 1998, 113 days after receiving the submission on January 26, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K980292 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1998
Decision Date May 19, 1998
Days to Decision 113 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MUS — Fluidic, Phacoemulsification/phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670