# K053551: Micromanipulation Media System, LG Hyaluronidase and LG Paraffin Oil

- Pathway: 510(k) (Traditional)
- Applicant: <Genx> Intl., Inc.
- Decided: May 9, 2006 after 140 days
- Product code: MQL (Media, Reproductive)
- Device class: 2
- Regulation: 21 CFR 884.6180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.

Source page: https://510kreport.com/device/K053551
Methodology: https://510kreport.com/methodology