# K172769: CryOmega Flexx

- Pathway: 510(k) (Traditional)
- Applicant: Cryoconcepts LP
- Decided: Nov 30, 2017 after 78 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K024009 (2003). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102006: Cryomega, Stc Consulting, LLC (2010) Summary page 4.

## Most influential descendants
- K203481: CryoVIVE (2021), 5 descendants of its own
- K220674: TargetCool (2022), 4 descendants of its own
- K221234: TargetCool (2022), 3 descendants of its own
- K230599: TargetCool™ (2023), 2 descendants of its own
- K253114: TargetCool™ (RM-DT02W) (2025), 0 descendants of its own

## Indications for use
The CryOmega Flexx is intended for the surgical destruction of tissue of target tissue by applying cryogenic gases at extreme low temperatures The List below shows examples of the types of lesions that may be treated: • Molluscum Contagiosum • Skin Tags • Actinic Keratosis • Lentigo • Verruca Plana • Verruca Vulgaris • Verruca Plantaris • Genital Lesions • Seborrheic Keratosis

Source page: https://510kreport.com/device/K172769
Methodology: https://510kreport.com/methodology