MML — Weights, Eyelid, External Class II
FDA product code MML covers "Weights, Eyelid, External", a Class II medical device regulated under 21 CFR 886.5700. Submissions are reviewed by the Ophthalmic panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MML
- Device Class
- Class II
- Regulation Number
- 886.5700
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170591 | altomed limited | Altomed Malhotra Platinum Segments | June 6, 2017 |
| K150986 | meddev corporation | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | August 17, 2015 |
| K021750 | jedmed instrument | LID CHAIN EYELID WEIGHTS | January 27, 2003 |
| K011740 | meddev | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) | July 2, 2001 |
| K011115 | heinz kurz gmbh medizintechnik | KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL | May 2, 2001 |
| K003646 | iop | SUTUREGROOVE WEIGHT SIZING SET | February 22, 2001 |
| K001123 | heinz kurz gmbh medizintechnik | KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 | April 21, 2000 |
| K994289 | iop | SUTUREGROOVE | April 17, 2000 |
| K000127 | heinz kurz gmbh medizintechnik | KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 | April 12, 2000 |
| K990224 | labtician ophthalmics | LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET | April 12, 1999 |
| K983607 | labtician ophthalmics | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | January 8, 1999 |
| K971242 | ipax | BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) | December 17, 1997 |
| K971245 | ipax | BLINK EXTERNAL EYELID WEIGHT | June 20, 1997 |
| K940974 | meddev | EYECLOSE EXTERNAL EYELID WEIGHTS | June 8, 1994 |