Cleared Traditional

SOFT LENS FOLDER

K861990 · Staar Surgical Co. · Ophthalmic
Jun 1986
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K861990 is an FDA 510(k) clearance for the SOFT LENS FOLDER, 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 June 17, 1986, 25 days after receiving the submission on May 23, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4300.

Submission Details

510(k) Number K861990 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1986
Decision Date June 17, 1986
Days to Decision 25 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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