MMLClass II

Weights, Eyelid, External

21 CFR 886.5700 / Ophthalmic

MML is the FDA product code for Weights, Eyelid, External, a class II device type, regulated under 21 CFR 886.5700. FDA's definition for this code reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". As of 2026-09-10, FDA records hold 14 510(k) clearances under this code, the most recent dated 2017-06-06, and no recalls.

Classification record

Product code: MML
Device name: Weights, Eyelid, External
FDA definition: Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Regulation: 21 CFR 886.5700
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 14
Ingested recalls: 0

Clearances, product code MML

By decision year

14 clearances under product code MML with a decision year between 1994 and 2017, 2000 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code MML by decision year
Year	Clearances
1994	1
1997	2
1999	2
2000	3
2001	3
2003	1
2015	1
2017	1

Applicants with the most clearances

Product code MML

Applicants holding the most 510(k) clearances under product code MML
Applicant	Clearances
Heinz Kurz GmbH Medizintechnik	3
Meddev Corp	3
Iop, Inc.	2
Ipax, Inc.	2
Labtician Ophthalmics, Inc.	2
Altomed Ltd.	1
JEDMED Instrument Company	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order