Weights, Eyelid, External
FDA product code MML · Class II (moderate risk) · 21 CFR 886.5700 · Ophthalmic
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
14510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170591 | Altomed Malhotra Platinum SegmentsMML · Traditional | Altomed Limited | 06/06/2017SE |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMML · Traditional | Meddev Corporation | 08/17/2015SE |
| K021750 | Lid Chain Eyelid WeightsMML · Traditional | Jedmed Instrument Co. | 01/27/2003SE |
| K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)MML · Special | Meddev Corp. | 07/02/2001SE |
| K011115 | Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007…MML · Special | Heinz Kurz GmbH Medizintechnik | 05/02/2001SE |
| K003646 | Suturegroove Weight Sizing SetMML · Traditional | Iop, Inc. | 02/22/2001SESK |
| K001123 | Kurz Upper Eyelid Implant Sizers, Model 8000 111MML · Traditional | Heinz Kurz GmbH Medizintechnik | 04/21/2000SE |
| K994289 | SuturegrooveMML · Traditional | Iop, Inc. | 04/17/2000SE |
| K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10MML · Traditional | Heinz Kurz GmbH Medizintechnik | 04/12/2000SE |
| K990224 | Labtician Lid Load External Eyelid Sizing SetMML · Traditional | Labtician Ophthalmics, Inc. | 04/12/1999SE |
| K983607 | Labtician Lid Load Gold Eyelid Weight ImplantsMML · Traditional | Labtician Ophthalmics, Inc. | 01/08/1999SE |
| K971242 | Blink Gold Evelid Weight (BG 06 Thru BG 28)MML · Traditional | Ipax, Inc. | 12/17/1997SE |
| K971245 | Blink External Eyelid WeightMML · Traditional | Ipax, Inc. | 06/20/1997SE |
| K940974 | Eyeclose External Eyelid WeightsMML · Traditional | Meddev Corp. | 06/08/1994SE |