Cleared Traditional

K940974 - EYECLOSE EXTERNAL EYELID WEIGHTS

K940974 is an FDA 510(k) clearance for EYECLOSE EXTERNAL EYELID WEIGHTS, manufactured by Meddev Corp.. The device is a Class 2 Ophthalmic device with product code MML cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K940974 · Meddev Corp. · Ophthalmic device
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Jun 1994
Decision
97d
Days
Class 2
Risk

K940974 is an FDA 510(k) clearance for the EYECLOSE EXTERNAL EYELID WEIGHTS. Classified as Weights, Eyelid, External (product code MML), Class II - Special Controls.

Submitted by Meddev Corp. (Los Altos, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 97 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 Corp. devices

FDA 510(k) Submission Details - K940974

510(k) Number K940974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date June 08, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 110d · This submission: 97d
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.