# K803311: LL100 Cryosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Feb 4, 1981 after 33 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K110754: Cryopen Cryosurgical System, K102214 (2011), 6 descendants of its own
- K161480: R2 Dermal Cooling System (2016), 5 descendants of its own
- K171398: Dermal Cooling System (2017), 4 descendants of its own
- K201260: Dermal Cooling System (2020), 3 descendants of its own
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System) (2021), 2 descendants of its own

## Recalls of this device
- Mar 9, 2015 · Class II · Z-1450-2015: Internal gas line may malfunction causing the line to burst under pressure.
- Jun 6, 2007 · Not classified · Z-1045-2007: The tip may separate from the probe.
- Jun 6, 2007 · Not classified · Z-1046-2007: The tip may separate from the probe.

Source page: https://510kreport.com/device/K803311
Methodology: https://510kreport.com/methodology