Cleared Traditional

KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

K001123 · Heinz Kurz GmbH Medizintechnik · Ophthalmic

Apr 2000

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K001123 is an FDA 510(k) clearance for the KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111, a Weights, Eyelid, External (Class II — Special Controls, product code MML), submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on April 21, 2000, 14 days after receiving the submission on April 7, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number	K001123 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2000
Decision Date	April 21, 2000
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	MML — Weights, Eyelid, External
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.5700
Definition	Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)