Cleared Traditional

STAAR PHACO XL SMALL INCISION SYSTEM

K884241 · Staar Surgical Co. · Ophthalmic
Feb 1989
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K884241 is an FDA 510(k) clearance for the STAAR PHACO XL SMALL INCISION SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on February 17, 1989, 129 days after receiving the submission on October 11, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K884241 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1988
Decision Date February 17, 1989
Days to Decision 129 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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