# K102021: Cryo-Touch II

- Pathway: 510(k) (Special)
- Applicant: Myoscience, Inc.
- Decided: Sep 17, 2010 after 60 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: 4 generations back to K781302 (1978). 9 ancestors in all.
9 later devices descend from it; 2 cite 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)
- K100447: Myoscience Cryo-Touch, Myoscience, Inc. (2010) Summary page 3.

## Most influential descendants
- K120415: Cryo-Touch Iii (2012), 8 descendants of its own
- K123516: Cryo-Touch IV (2013), 7 descendants of its own
- K133453: Iovera (2014), 6 descendants of its own
- K142866: Myoscience iovera system (2015), 5 descendants of its own
- K161835: iovera system (2017), 4 descendants of its own

## Indications for use
The MyoScience Cryo-Touch II is used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch II is not indicated for treatment of central nervous system tissue.

Source page: https://510kreport.com/device/K102021
Methodology: https://510kreport.com/methodology