510(k) · Cleared
Recalled · Class II · 2015LL100 Cryosurgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallach Surgical Devices, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Feb 4, 1981 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 4, 1981
- Review
- 33 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 3
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK803311 LL100 Cryosurgical SystemWallach Surgical Devices, Inc. · 1981
- Descendant · cites it directly · 6 of its ownK110754 Cryopen Cryosurgical System, K102214Cryopen, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · 3 generations on · 4 of its ownK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- Descendant · 4 generations on · 3 of its ownK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- Descendant · 5 generations on · 2 of its ownK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K110754Cryopen Cryosurgical System, K102214Cryopen, Inc. · 2011 · cites it directly6descendants
- K161480R2 Dermal Cooling SystemR2 Dermatology · 2016 · 2 generations on5descendants
- K171398Dermal Cooling SystemR2 Dermatology,Inc · 2017 · 3 generations on4descendants
- K201260Dermal Cooling SystemR2 Technologies, Inc. · 2020 · 4 generations on3descendants
- K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K803311 | LL100 Cryosurgical System | Wallach Surgical Devices, Inc. | 1981 | — |
| +1 | K110754 | Cryopen Cryosurgical System, K102214 | Cryopen, Inc. | 2011 | — |
| +2 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +3 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| +4 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| +5 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2015 | Class II | Z-1450-2015 | Under Investigation by firm | Internal gas line may malfunction causing the line to burst under pressure. |
| Jun 6, 2007 | Not classified | Z-1045-2007 | Device Design | The tip may separate from the probe. |
| Jun 6, 2007 | Not classified | Z-1046-2007 | Device Design | The tip may separate from the probe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110754 (Cryopen, Inc., 2011) has gone furthest, with 6 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
https://510kreport.com/device/K803311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K803311: LL100 Cryosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K803311
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026