# K933327: Histofreezer

- Pathway: 510(k) (Traditional)
- Applicant: Solarcare, Inc.
- Decided: Oct 29, 1993 after 113 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
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), 8 descendants of its own
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K243487: CryoFreeze Wart and Skin Tag Remover (2025), 1 descendant of its own
- K240226: Pixie Skin Tag (2024), 1 descendant of its own
- K252198: Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K933327
Methodology: https://510kreport.com/methodology