# K180211: Freezpoint

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical Corp.
- Decided: Mar 21, 2018 after 55 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.
No later device cites it as a predicate yet.
0 of 3 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 5.

## Indications for use
The Freezpoint device 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/K180211
Methodology: https://510kreport.com/methodology