510(k) · Cleared
ClearedCool Renewal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cool Renewal, LLC · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 6, 2016 as substantially equivalent to K130995 (Nuance Medical, LLC, 2013) after a 58-day review. Its family tree reaches back 2 generations to 1988. 12 later devices descend from it.
- Decided
- Jul 6, 2016
- Review
- 58 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881349 (1988). 4 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK881349 Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988
- 1 generation backK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
- This deviceK161296 Cool RenewalCool Renewal, LLC · 2016
- Descendant · cites it directly · 9 of its ownK190747 ClaritagDgi Technologies · 2019
- Descendant · 2 generations on · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
- Descendant · 3 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
- Descendant · 3 generations on · 1 of its ownK243487 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK240226 Pixie Skin TagOystershell NV · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K190747ClaritagDgi Technologies · 2019 · cites it directly9descendants
- K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022 · 2 generations on8descendants
- K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 3 generations on1descendant
- K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 3 generations on1descendant
- K240226Pixie Skin TagOystershell NV · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881349 | Verruca-Freeze (TM) Cryotherapy Delivery System | Cryosurg, Inc. | 1988 | — |
| −1 | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray | Nuance Medical, LLC | 2013 | — |
| 0 (this device) | K161296 | Cool Renewal | Cool Renewal, LLC | 2016 | — |
| +1 | K190747 | Claritag | Dgi Technologies | 2019 | — |
| +2 | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022 | — |
| +3 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
| +3 | K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +3 | K240226 | Pixie Skin Tag | Oystershell NV | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 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 |
|---|---|---|---|
| * | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SpraySummary page 4…EH Device Class: Class II Classification Panel: General & Plastic Surgery 5. Legally Marketed Predicate Device(s) Nuance Freeze Spray (K130995) manufactured by Nuance Medical, LLC is the primary predicate device. Page 1 o… | 2013 |
What descends from it? (12)
See all 122 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)
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 28 years and passes through 3 companies; a new generation was cleared every 25.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K190747 (Dgi Technologies, 2019) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K130995.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts)
including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age
spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma,
chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161296: Cool Renewal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161296
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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