# MML: Weights, Eyelid, External

- Device class: 2; regulation: 21 CFR 886.5700; FDA's rule: 510(k) exempt
- FDA decisions: 14
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 1
- 1997: 2
- 1999: 2
- 2000: 3
- 2001: 3
- 2003: 1
- 2015: 1
- 2017: 1

## Most-cited predicates
- K150986: Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (2015), cited by 1
- K011740: Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) (2001), cited by 1
- K940974: Eyeclose External Eyelid Weights (1994), cited by 1
- K011115: Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007 002, 4007 008-010 (2001), cited by 1
- K983607: Labtician Lid Load Gold Eyelid Weight Implants (1999), cited by 1

Source page: https://510kreport.com/product-code/MML
Data by year (CSV): https://510kreport.com/product-code/MML.csv