MML — Weights, Eyelid, External Class II

FDA Device Classification

Classification Details

Product Code
MML
Device Class
Class II
Regulation Number
886.5700
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170591altomed limitedAltomed Malhotra Platinum SegmentsJune 6, 2017
K150986meddev corporationContour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsAugust 17, 2015
K021750jedmed instrumentLID CHAIN EYELID WEIGHTSJanuary 27, 2003
K011740meddevCONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)July 2, 2001
K011115heinz kurz gmbh medizintechnikKURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIALMay 2, 2001
K003646iopSUTUREGROOVE WEIGHT SIZING SETFebruary 22, 2001
K001123heinz kurz gmbh medizintechnikKURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111April 21, 2000
K994289iopSUTUREGROOVEApril 17, 2000
K000127heinz kurz gmbh medizintechnikKURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10April 12, 2000
K990224labtician ophthalmicsLABTICIAN LID LOAD EXTERNAL EYELID SIZING SETApril 12, 1999
K983607labtician ophthalmicsLABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTSJanuary 8, 1999
K971242ipaxBLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)December 17, 1997
K971245ipaxBLINK EXTERNAL EYELID WEIGHTJune 20, 1997
K940974meddevEYECLOSE EXTERNAL EYELID WEIGHTSJune 8, 1994