# K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector)

- Pathway: 510(k) (Traditional)
- Applicant: Dutch Ophthalmic Research Center International BV
- Decided: Mar 13, 2015 after 163 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933880 (1994). 53 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081877: Associate 2500 Dual and Compact Systems, Dutch Ophthalmic Research Center International BV (2009) Summary page 4.
- K101285: Constellation Vision System, Alcon Manufacturing, Ltd. (2010) Summary page 4.
- K101325: Stellaris PC Vision Enhancement System, Bausch & Lomb, Inc. (2010) Summary page 4.
- K102222: Ultimate Vit Enhamcer (Uve), Medical Instrument Development Laboratories, Inc. (2011) Summary page 4.
- K121675: Versavit, Synergetics, Inc. (2012) Summary page 4.
- K062624: Next Generation Laser, Alcon Laboratories (2007) Summary page 4.

## Most influential descendants
- K190875: EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) (2019), 2 descendants of its own
- K213467: EVA NEXUS Ophthalmic Surgical System (2022), 1 descendant of its own
- K212241: Quatera 700 (2022), 1 descendant of its own
- K250501: System Sophi (2025), 0 descendants of its own
- K230858: Quatera 700 (2023), 0 descendants of its own

## Indications for use
The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. In addition, the optional laser is indicated for the following: Condition Treatment Diabetic Retinopathy x Proliferative Diabetic Retinopathy Panretinal Photocoagulation x Clinically Significant Macular Edema Focal or Grid Laser Retinal Tear and Detachments Laser Retinopathy Lattice Degeneration Retinal Photocoagulation Sub-retinal (choroidal) Neovascularization Focal Laser Retinal Vascular Occlusion x Neovascularization secondary to Brand or Central retinal Scatter Laser vein occlusion Photocoagulation x Chronic macular edema secondary to Branch or Central Focal or Grid Laser retinal vein occlusion Glaucoma x Primary Open-angle Trabeculoplasty x Closed Angle Iridotomy or Iridoplasty

Source page: https://510kreport.com/device/K142877
Methodology: https://510kreport.com/methodology