# K212241: Quatera 700

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Apr 19, 2022 after 274 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: 8 generations back to K933880 (1994). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector), Dutch Ophthalmic Research Center International BV (2015) Summary page 5.

## Most influential descendants
- K230858: Quatera 700 (2023), 0 descendants of its own

## Indications for use
QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.

Source page: https://510kreport.com/device/K212241
Methodology: https://510kreport.com/methodology