Weights, Eyelid, External
The External Eyelid Weight is a small, adhesive weight, typically made of gold or another biocompatible material, applied externally to the upper eyelid to assist gravity-assisted closure of the eyelid in patients with lagophthalmos, the inability to fully close the eye, which can result from facial nerve palsy or other conditions causing incomplete blink. Classified as a Class 2 device under 21 CFR 886.5700 within the Ophthalmic specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MML
- Device Class
- FDA class 2
- Regulation Number
- 886.5700
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170591 | Altomed Malhotra Platinum Segments | Jun 06, 2017 | Substantially Equivalent | Altomed Limited |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Aug 17, 2015 | Substantially Equivalent | Meddev Corporation |
| K021750 | LID CHAIN EYELID WEIGHTS | Jan 27, 2003 | Substantially Equivalent | Jedmed Instrument Co. |
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Jul 02, 2001 | Substantially Equivalent | Meddev Corp. |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | May 02, 2001 | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Feb 22, 2001 | Unknown | Iop, Inc. |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Apr 21, 2000 | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik |
| K994289 | SUTUREGROOVE | Apr 17, 2000 | Substantially Equivalent | Iop, Inc. |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Apr 12, 2000 | Substantially Equivalent | Heinz Kurz GmbH Medizintechnik |
| K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | Apr 12, 1999 | Substantially Equivalent | Labtician Ophthalmics, Inc. |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | Jan 08, 1999 | Substantially Equivalent | Labtician Ophthalmics, Inc. |
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | Dec 17, 1997 | Substantially Equivalent | Ipax, Inc. |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Jun 20, 1997 | Substantially Equivalent | Ipax, Inc. |
| K940974 | EYECLOSE EXTERNAL EYELID WEIGHTS | Jun 08, 1994 | Substantially Equivalent | Meddev Corp. |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.