510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150986Substantially Equivalent

Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants

Meddev Corp, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150986 is the FDA 510(k) clearance record for Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants, a class II device, cleared for Meddev Corporation 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 Corporation, from to . As of , FDA records show 2 recalls naming K150986.

Clearance record

Decision date
Received
(125 days to decision)
Product code
MML Weights, Eyelid, External
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Applicant
Meddev Corporation 730 N. Pastoria Ave., Sunnyvale CA
510(k) summary
Summary PDF
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