Cleared Special

K011115 - KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011115 · Heinz Kurz GmbH Medizintechnik · Ophthalmic device
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May 2001
Decision
20d
Days
Class 2
Risk

K011115 is an FDA 510(k) clearance for the KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPEC.... Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on May 2, 2001 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5700 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Heinz Kurz GmbH Medizintechnik devices

Submission Details

510(k) Number K011115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MML Weights, Eyelid, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5700
Definition Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.