# K102006: Cryomega

- Pathway: 510(k) (Traditional)
- Applicant: Stc Consulting, LLC
- Decided: Oct 6, 2010 after 82 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: 1 generation back to K024009 (2003). 1 ancestor in all.
8 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024009: Cryoprobe, H&O Equipments, Nv/Sa (2003) Summary page 1.

## Most influential descendants
- K172769: CryOmega Flexx (2017), 6 descendants of its own
- 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

## Indications for use
The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated. -Genital Lesions -Molluscumn Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana -Actinic Keratosis -Lentigo

Source page: https://510kreport.com/device/K102006
Methodology: https://510kreport.com/methodology