MML · Class II · 21 CFR 886.5700

FDA Product Code MML: Weights, Eyelid, External

Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)

Leading manufacturers include Heinz Kurz GmbH Medizintechnik, Ipax, Inc. and Labtician Ophthalmics, Inc..

14
Total
14
Cleared
101d
Avg days
1994
Since

FDA 510(k) Cleared Weights, Eyelid, External Devices (Product Code MML)

14 devices
1–14 of 14
Cleared Jun 06, 2017
Altomed Malhotra Platinum Segments
K170591
Altomed Limited
Ophthalmic · 98d
Cleared Aug 17, 2015
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
K150986
Meddev Corporation
Ophthalmic · 125d
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jul 02, 2001
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
K011740
Meddev Corp.
Ophthalmic · 27d
Cleared May 02, 2001
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
K011115
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 20d
Cleared Feb 22, 2001
SUTUREGROOVE WEIGHT SIZING SET
K003646
Iop, Inc.
Ophthalmic · 87d
Cleared Apr 21, 2000
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
K001123
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 14d
Cleared Apr 17, 2000
SUTUREGROOVE
K994289
Iop, Inc.
Ophthalmic · 118d
Cleared Apr 12, 2000
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
K000127
Heinz Kurz GmbH Medizintechnik
Ophthalmic · 85d
Cleared Apr 12, 1999
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
K990224
Labtician Ophthalmics, Inc.
Ophthalmic · 77d
Cleared Jan 08, 1999
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607
Labtician Ophthalmics, Inc.
Ophthalmic · 86d
Cleared Dec 17, 1997
BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28)
K971242
Ipax, Inc.
Ophthalmic · 259d
Cleared Jun 20, 1997
BLINK EXTERNAL EYELID WEIGHT
K971245
Ipax, Inc.
Ophthalmic · 78d

About Product Code MML - Regulatory Context