Cleared Traditional

K150986 - Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants

K150986 is an FDA 510(k) clearance for Contour Eyelid Weight Implants, manufactured by Meddev Corporation. The device is a Class 2 Ophthalmic device with product code MML cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K150986 · Meddev Corporation · Ophthalmic device
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Aug 2015
Decision
125d
Days
Class 2
Risk

K150986 is an FDA 510(k) clearance for the Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Meddev Corporation (Sunnyvale, US). The FDA issued a Cleared decision on August 17, 2015 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5700 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Meddev Corporation devices

FDA 510(k) Submission Details - K150986

510(k) Number K150986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2015
Decision Date August 17, 2015
Days to Decision 125 days
Submission Type Traditional
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
15d slower than avg
Panel avg: 110d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 7
Devices cleared under the same product code (MML) and FDA review panel - the closest regulatory comparables to K150986.
Altomed Malhotra Platinum Segments
K170591 · Altomed Limited · Jun 2017
LID CHAIN EYELID WEIGHTS
K021750 · Jedmed Instrument Co. · Jan 2003
SUTUREGROOVE
K994289 · Iop, Inc. · Apr 2000
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224 · Labtician Ophthalmics, Inc. · Apr 1999
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607 · Labtician Ophthalmics, Inc. · Jan 1999
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242 · Ipax, Inc. · Dec 1997