Cleared Special

KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

K011115 · Heinz Kurz GmbH Medizintechnik · Ophthalmic

May 2001

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K011115 is an FDA 510(k) clearance for the KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010, 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 May 2, 2001, 20 days after receiving the submission on April 12, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number	K011115 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2001
Decision Date	May 02, 2001
Days to Decision	20 days
Submission Type	Special
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)