Cleared Special

K011740 - CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)

K011740 is an FDA 510(k) clearance for CONTOUR DESIGN GOLD EYELID IMPLANT, manufactured by Meddev Corp.. The device is a Class 2 Ophthalmic device with product code MML cleared through the Special 510(k) pathway after a 27-day FDA review.

K011740 · Meddev Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
27d
Days
Class 2
Risk

K011740 is an FDA 510(k) clearance for the CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000). Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Meddev Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 27 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.

FDA 510(k) Submission Details - K011740

510(k) Number K011740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2001
Decision Date July 02, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

MML Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MML Weights, Eyelid, External

All 13
Devices cleared under the same product code (MML) and FDA review panel - the closest regulatory comparables to K011740.
Altomed Malhotra Platinum Segments
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Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986 · Meddev Corporation · Aug 2015
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
K011115 · Heinz Kurz GmbH Medizintechnik · May 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646 · Iop, Inc. · Feb 2001
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123 · Heinz Kurz GmbH Medizintechnik · Apr 2000
K011740 · CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
Download PDF FDA Summary Meddev Corp.