Cleared Traditional

ULTRAKIT

K831172 · Staar Surgical Co. · Ophthalmic
Jun 1983
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K831172 is an FDA 510(k) clearance for the ULTRAKIT, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Staar Surgical Co. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 58 days after receiving the submission on April 11, 1983. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K831172 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1983
Decision Date June 08, 1983
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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