# K133453: Iovera

- Pathway: 510(k) (Traditional)
- Applicant: Myoscience, Inc.
- Decided: Mar 24, 2014 after 132 days
- Product code: GXH (Device, Surgical, Cryogenic)
- Device class: 2
- Regulation: 21 CFR 882.4250
- 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 K781302 (1978). 12 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123516: Cryo-Touch IV, Myoscience, Inc. (2013) Summary page 1.

## Most influential descendants
- K142866: Myoscience iovera system (2015), 5 descendants of its own
- K161835: iovera system (2017), 4 descendants of its own
- K211334: Iovera System (2021), 2 descendants of its own
- K173763: iovera system (2018), 2 descendants of its own
- K220656: iovera System (2022), 1 descendant of its own

## Indications for use
The myoscience iovera0 device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera0 device is not indicated for treatment of central nervous system tissue.

Source page: https://510kreport.com/device/K133453
Methodology: https://510kreport.com/methodology