FDA product code MML: Weights, Eyelid, External
MML is the FDA product code for weights, eyelid, external. It is a Class II device, regulated under 21 CFR 886.5700 and reviewed by the Ophthalmic panel. FDA has cleared 14 510(k) submissions under MML, from 8 different applicants. The average 510(k) review took 101 days (median 86).
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Classification
| Field | Value |
|---|---|
| Device name | Weights, Eyelid, External |
| Device class | Class II |
| Regulation | 21 CFR 886.5700 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
510(k) clearances per year for MML
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 98 |
Compare with all 510(k) review times · Search every MML clearance
Top MML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Heinz Kurz GmbH Medizintechnik | 3 | 2001-05-02 |
| Meddev Corp. | 2 | 2001-07-02 |
| Iop, Inc. | 2 | 2001-02-22 |
| Labtician Ophthalmics, Inc. | 2 | 1999-04-12 |
| Ipax, Inc. | 2 | 1997-12-17 |
3 more applicants have MML clearances. See the full list in Caduvo.
Most recent MML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170591 | Altomed Limited | Altomed Malhotra Platinum Segments | 2017-06-06 | 98 |
| K150986 | Meddev Corporation | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | 2015-08-17 | 125 |
| K021750 | Jedmed Instrument Co. | LID CHAIN EYELID WEIGHTS | 2003-01-27 | 244 |
| K011740 | Meddev Corp. | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | 2001-07-02 | 27 |
| K011115 | Heinz Kurz GmbH Medizintechnik | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | 2001-05-02 | 20 |
Recalls for MML devices
openFDA lists no recalls for product code MML.
Frequently asked questions
What is FDA product code MML?
MML is the FDA product code for weights, eyelid, external. It is a Class II device, regulated under 21 CFR 886.5700 and reviewed by the Ophthalmic panel.
What device class is MML?
Class II, regulation 21 CFR 886.5700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MML?
Across 14 cleared submissions the average was 101 days from receipt to decision (median 86).
Which companies have the most MML clearances?
Heinz Kurz GmbH Medizintechnik (3); Meddev Corp. (2); Iop, Inc. (2); Labtician Ophthalmics, Inc. (2); Ipax, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MML
- Run a recall and safety report across every MML manufacturer
- Watch product code MML for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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