Cleared Traditional

TURBOSONICS LIMITED REUSE ULTRASONIC TIP

K981103 · Alcon Laboratories · Ophthalmic
Jun 1998
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K981103 is an FDA 510(k) clearance for the TURBOSONICS LIMITED REUSE ULTRASONIC TIP, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on June 23, 1998, 89 days after receiving the submission on March 26, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K981103 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1998
Decision Date June 23, 1998
Days to Decision 89 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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