Cleared Traditional

STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT

K851936 · Staar Surgical Co. · Ophthalmic
Aug 1985
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K851936 is an FDA 510(k) clearance for the STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on August 20, 1985, 106 days after receiving the submission on May 6, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K851936 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1985
Decision Date August 20, 1985
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

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