510(k) · Cleared
ClearedFreeze’n Clear Skin Clinic Warts & Tags
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryoconcepts LP · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 17, 2022 as substantially equivalent to K023487 (OraSure Technologies, Inc., 2003) and 2 other predicates after a 430-day review. Its family tree reaches back 4 generations to 1988. 8 later devices descend from it.
- Decided
- Jun 17, 2022
- Review
- 430 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K881349 (1988). 12 ancestors in all. 8 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK881349 Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988
- 3 generations backK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
- 2 generations backK161296 Cool RenewalCool Renewal, LLC · 2016
- 1 generation backK190747 ClaritagDgi Technologies · 2019
- This deviceK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
- Descendant · cites it directly · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
- Descendant · cites it directly · 1 of its ownK243487 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK240226 Pixie Skin TagOystershell NV · 2024
- Descendant · cites it directly · 0 of its ownK252198 Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026
- Descendant · 2 generations on · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · cites it directly1descendant
- K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · cites it directly1descendant
- K240226Pixie Skin TagOystershell NV · 2024 · cites it directly1descendant
- K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026 · cites it directly0descendants
- K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881349 | Verruca-Freeze (TM) Cryotherapy Delivery System | Cryosurg, Inc. | 1988 | — |
| −3 | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray | Nuance Medical, LLC | 2013 | — |
| −2 | K161296 | Cool Renewal | Cool Renewal, LLC | 2016 | — |
| −1 | K190747 | Claritag | Dgi Technologies | 2019 | — |
| 0 (this device) | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022 | — |
| +1 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
| +1 | K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +1 | K240226 | Pixie Skin Tag | Oystershell NV | 2024 | — |
| +1 | K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 K230551 Visual-ICE Cryoablation Systemscore 17.2 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K023487 | Histofreezer Wart Removal System or Other Proprietary NameSummary page 4…cation Name – General & Plastic Surgery Regulatory Class: II Code of Federal Regulation: 878.4350 Product Code: GEH III. PREDICATE DEVICES OTC Wart Removal System K023487 Histofreezer Professional K933327 Claritag K190747 IV. DEVICE DESCRIPTION The Freeze ‘n Clear Skin Clinic for Warts and Sk… | 2003 |
| * | K933327 | HistofreezerSummary page 4…gery Regulatory Class: II Code of Federal Regulation: 878.4350 Product Code: GEH III. PREDICATE DEVICES OTC Wart Removal System K023487 Histofreezer Professional K933327 Claritag K190747 IV. DEVICE DESCRIPTION The Freeze ‘n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme co… | 1993 |
| * | K190747 | ClaritagSummary page 4…lass: II Code of Federal Regulation: 878.4350 Product Code: GEH III. PREDICATE DEVICES OTC Wart Removal System K023487 Histofreezer Professional K933327 Claritag K190747 IV. DEVICE DESCRIPTION The Freeze ‘n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate t… | 2019 |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242932 | Skin Clinic Nitro Clear Wart Remover | 2025 | 1 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | 2025 | 1 |
| K240226 | Pixie Skin Tag | 2024 | 1 |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | 2026 | 0 |
| K242803 | Compound W Skin Tag Remover | 2024 | 0 |
| K242625 | Freeze Point & Private Label Versions | 2024 | 0 |
| K222356 | Claritag Advanced | 2023 | 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 34 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K242932 (Cryoconcepts LP, 2025) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K023487.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211099: Freeze’n Clear Skin Clinic Warts & Tags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211099
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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