510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940974Substantially Equivalent

Eyeclose External Eyelid Weights

Meddev Corp, Los Altos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940974 is the FDA 510(k) clearance record for EYECLOSE EXTERNAL EYELID WEIGHTS, a class II device, cleared for Meddev Corp. on under FDA product code MML (Weights, Eyelid, External). FDA's definition for product code MML reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". FDA records list 3 510(k) clearances for Meddev Corp., from to . As of , FDA records show no recalls naming K940974.

Clearance record

Decision date
Received
(97 days to decision)
Product code
MML Weights, Eyelid, External
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Applicant
Meddev Corp. P.O. Box 1352, Los Altos CA
510(k) summary
Summary
Third party review
No

Clearances, product code MML

Trailing 12 months

FDA records hold no clearances under product code MML in the trailing twelve months.

FDA records show no clearances under product code MML in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MML, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260