MML · Weights, Eyelid, External
Ophthalmic · 21 CFR 886.5700 · Class 2
Overview
| Product Code | MML |
|---|---|
| Device Name | Weights, Eyelid, External |
| Regulation | 21 CFR 886.5700 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid. (2) The implantable eyelid weight is implanted into the upper eyelid.
Classification Rationale
(1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.
Special Controls
*Classification.* (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and (ii) Labeling must include the following information: (A) Specific instructions regarding the proper placement, sizing, and removal of the device; and (B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment. (2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are: (i) Testing demonstrating the biocompatibility of the device; (ii) Testing demonstrating the sterility and shelf life of the device; (iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment. (iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170591 | Altomed Malhotra Platinum Segments | Altomed Limited | Jun 6, 2017 | SESE |
| K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | Aug 17, 2015 | SESE |
| K021750 | LID CHAIN EYELID WEIGHTS | Jedmed Instrument Co. | Jan 27, 2003 | SESE |
| K011740 | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | Meddev Corp. | Jul 2, 2001 | SESE |
| K011115 | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 | Heinz Kurz GmbH Medizintechnik | May 2, 2001 | SESE |
| K003646 | SUTUREGROOVE WEIGHT SIZING SET | Iop, Inc. | Feb 22, 2001 | SESK |
| K001123 | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | Heinz Kurz GmbH Medizintechnik | Apr 21, 2000 | SESE |
| K994289 | SUTUREGROOVE | Iop, Inc. | Apr 17, 2000 | SESE |
| K000127 | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | Heinz Kurz GmbH Medizintechnik | Apr 12, 2000 | SESE |
| K990224 | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | Labtician Ophthalmics, Inc. | Apr 12, 1999 | SESE |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | Labtician Ophthalmics, Inc. | Jan 8, 1999 | SESE |
| K971242 | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | Ipax, Inc. | Dec 17, 1997 | SESE |
| K971245 | BLINK EXTERNAL EYELID WEIGHT | Ipax, Inc. | Jun 20, 1997 | SESE |
| K940974 | EYECLOSE EXTERNAL EYELID WEIGHTS | Meddev Corp. | Jun 8, 1994 | SESE |
Top Applicants
- Heinz Kurz GmbH Medizintechnik — 3 clearances
- Iop, Inc. — 2 clearances
- Ipax, Inc. — 2 clearances
- Labtician Ophthalmics, Inc. — 2 clearances
- Meddev Corp. — 2 clearances
