510(k) · Cleared
ClearedCryoFreeze Wart and Skin Tag Remover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryosurgery, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 13, 2025 as substantially equivalent to K211099 (Cryoconcepts LP, 2022) after a 125-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Mar 13, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881349 (1988). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK881349 Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988
- 4 generations backK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
- 3 generations backK161296 Cool RenewalCool Renewal, LLC · 2016
- 2 generations backK190747 ClaritagDgi Technologies · 2019
- 1 generation backK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
- This deviceK243487 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881349 | Verruca-Freeze (TM) Cryotherapy Delivery System | Cryosurg, Inc. | 1988 | — |
| −4 | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray | Nuance Medical, LLC | 2013 | — |
| −3 | K161296 | Cool Renewal | Cool Renewal, LLC | 2016 | — |
| −2 | K190747 | Claritag | Dgi Technologies | 2019 | — |
| −1 | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022 | — |
| 0 (this device) | K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +1 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211099 | Freeze’n Clear Skin Clinic Warts & TagsSummary page 5…2 5. Predicate Device Device Name Freeze 'n Clear Skin Clinic for Warts and Skin Tags 510(k) Number K211099 Regulation Number 878.4350 - Cryosurgical unit and accessories Product Code GEH… | 2022 |
| † | K243454 | Verruca-Freeze H | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253000 | CryoFreeze Wart and Skin Tag Remover | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K253000 (Cryosurgery, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K211099.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The CryoFreeze Wart and Skin Tag Remover is intended for use in the over-the-counter treatment of common warts and
plantar warts in adults and children age 4 years or older and over-the-counter treatment of skin tags in adults age 22 years
or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243487: CryoFreeze Wart and Skin Tag Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243487
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026