Product code MML
- Device name
- Weights, Eyelid, External
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5700
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170591 | Altomed Malhotra Platinum Segments | Altomed Limited | 2017-06-06 |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | 2015-08-17 |
| K021750 | LID CHAIN EYELID WEIGHTS | Jedmed Instrument Co. | 2003-01-27 |
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Meddev Corp. | 2001-07-02 |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | Heinz Kurz GmbH Medizintechnik | 2001-05-02 |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Iop, Inc. | 2001-02-22 |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Heinz Kurz GmbH Medizintechnik | 2000-04-21 |
| K994289 | SUTUREGROOVE | Iop, Inc. | 2000-04-17 |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Heinz Kurz GmbH Medizintechnik | 2000-04-12 |
| K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | Labtician Ophthalmics, Inc. | 1999-04-12 |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | Labtician Ophthalmics, Inc. | 1999-01-08 |
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | Ipax, Inc. | 1997-12-17 |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Ipax, Inc. | 1997-06-20 |
| K940974 | EYECLOSE EXTERNAL EYELID WEIGHTS | Meddev Corp. | 1994-06-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EHKM80001111 | Test Weight Set Upper Eyelid Implant | Heinz Kurz GmbH | 2026-04-07 |
| 00813142021440 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021587 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021570 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021563 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021556 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021549 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021532 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021525 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021518 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021501 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021495 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021488 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021471 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021464 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021457 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021433 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021426 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021419 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021402 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021396 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021389 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021372 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021365 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021358 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021341 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021334 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021327 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021310 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |
| 00813142021303 | Blinkeze | MEDDEV CORPORATION | 2023-11-28 |