Atlas FDA

MML

14 FDA 510(k) clearances · Product code

87 daysmedian time to decision
244 days90th percentile
14clearances measured

FDA profile

Official device name
Weights, Eyelid, External
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5700
Medical specialty
Ophthalmic
FDA definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Altomed Malhotra Platinum Segments (K170591)Altomed Limited2017-06-06
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (K150986)Meddev Corporation2015-08-17
LID CHAIN EYELID WEIGHTS (K021750)Jedmed Instrument Co.2003-01-27
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (K011740)Meddev Corp.2001-07-02
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 (K011115)Heinz Kurz GmbH Medizintechnik2001-05-02
SUTUREGROOVE WEIGHT SIZING SET (K003646)Iop, Inc.2001-02-22
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (K001123)Heinz Kurz GmbH Medizintechnik2000-04-21
SUTUREGROOVE (K994289)Iop, Inc.2000-04-17
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (K000127)Heinz Kurz GmbH Medizintechnik2000-04-12
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (K990224)Labtician Ophthalmics, Inc.1999-04-12
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS (K983607)Labtician Ophthalmics, Inc.1999-01-08
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (K971242)Ipax, Inc.1997-12-17
BLINK EXTERNAL EYELID WEIGHT (K971245)Ipax, Inc.1997-06-20
EYECLOSE EXTERNAL EYELID WEIGHTS (K940974)Meddev Corp.1994-06-08

Track MML automatically

Every clearance here is in the API, with alerts when new ones post.