Cleared Traditional

ELASTIC LENS INJECTOR TM

K861085 · Staar Surgical Co. · Ophthalmic
May 1986
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K861085 is an FDA 510(k) clearance for the ELASTIC LENS INJECTOR TM, a Lens, Guide, Intraocular (Class I — General Controls, product code KYB), submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on May 28, 1986, 68 days after receiving the submission on March 21, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K861085 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1986
Decision Date May 28, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code KYB — Lens, Guide, Intraocular
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4300

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