510(k) Report

510(k) · Cleared

Cleared

Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray

K130995510(k) TraditionalCleared Jun 14, 201365-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuance Medical, LLC · GEH Unit, Cryosurgical, Accessories

Cleared on Jun 14, 2013 as substantially equivalent to K982506 (Cryosurgery, Inc., 1999) and 2 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1988. 16 later devices descend from it.

Decided
Jun 14, 2013
Review
65 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K881349 (1988). 3 ancestors in all. 16 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1994: 1 other ancestor2025: 4 descendants cleared2021: 2 descendants cleared2024: 4 descendants cleared2016: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant clearedK881349 · Verruca-Freeze (TM) Cryotherapy Delivery System · Cryosurg, Inc. · 19881990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant K881349 · Verruca-Freeze (TM) Cryotherapy Delivery System · Cryosurg, Inc. · 19880+5
  1. Root · 1 generation backK881349 Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc. · 1988
  2. This deviceK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
  3. Descendant · cites it directly · 12 of its ownK161296 Cool RenewalCool Renewal, LLC · 2016
  4. Descendant · 2 generations on · 9 of its ownK190747 ClaritagDgi Technologies · 2019
  5. Descendant · 3 generations on · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
  6. Descendant · 4 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
  7. Descendant · 4 generations on · 1 of its ownK243487 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2016: 12019: 12021: 22022: 12023: 22024: 42025: 42026: 1
2016high 4 (2024) · low 0 (2017)2026

Most influential descendants

Showing 5 of 16 · See all
  • K161296Cool RenewalCool Renewal, LLC · 2016 · cites it directly12descendants
  • K190747ClaritagDgi Technologies · 2019 · 2 generations on9descendants
  • K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022 · 3 generations on8descendants
  • K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 4 generations on1descendant
  • K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K881349Verruca-Freeze (TM) Cryotherapy Delivery SystemCryosurg, Inc.1988—
0 (this device)K130995Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC2013—
+1K161296Cool RenewalCool Renewal, LLC2016—
+2K190747ClaritagDgi Technologies2019—
+3K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP2022—
+4K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025—
+4K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201910
202120
202210
202320
202440
202540
202610
FIG. 1 — Lineage of K130995, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K982506Verruca-Freeze Cryosurgery Delivery System
Summary page 1
…ane or R-404a Class II - “Unit, Cryosurgical Accessories” (Regulation 21CFR 878.4350; Product Code: GEH) Cryosurgery, Inc. : Verruca-Freeze Cryosurgery Delivery System K982506 Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System K881349 Cryosurgery, Inc. Verruca-Freeze Cryosurgical Delivery Sys…
Cryosurgery, Inc.1999—
*K881349Verruca-Freeze (TM) Cryotherapy Delivery System
Summary page 1
…21CFR 878.4350; Product Code: GEH) Cryosurgery, Inc. : Verruca-Freeze Cryosurgery Delivery System K982506 Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System K881349 Cryosurgery, Inc. Verruca-Freeze Cryosurgical Delivery System K944221 G, K130995 - Page 2 of 2 Description of…
Cryosurg, Inc.1988—
*K944221Verruca-Freeze (TM) Cryosurgical Delivery Syst, Modified
Summary page 1
…Cryosurgery Delivery System K982506 Cryosurgery, Inc. Verruca-Freeze Cryosurgery Delivery System K881349 Cryosurgery, Inc. Verruca-Freeze Cryosurgical Delivery System K944221 G, K130995 - Page 2 of 2 Description of the Device: The Nuance Freeze Spray System is used in the practice of…
Cryosurgery, Inc.1994—

Also cleared against K982506: 2 other devices →

What descends from it? (16)

See all 16

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161296Cool RenewalCool Renewal, LLC201612
K252903Verruca-Freeze H PlusCryosurgery, Inc.20250
K240106Histofreezer VCryoconcepts LP20240
K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitNuance Medical, LLC20210

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K161296 (Cool Renewal, LLC, 2016) has gone furthest, with 12 descendants of its own.
  • 2 other devices also cite its predicate K982506.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

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 keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K982506

2 other devices cite the same predicate.

  • K152203Utermohlen Cryo ProfessionalKoninklijke (Royal) Utermohlen · 2015
  • K103310Cryonize TM3jt Enterprises, LLC · 2011

More from Nuance Medical, LLC

6 FDA decisions under this applicant name. See the company

  • K232674PainFreeze IINuance Medical, LLC · 2024
  • K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitNuance Medical, LLC · 2021
  • K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC · 2017
  • K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC · 2016
  • K161337CryoDose H or SimilarNuance Medical, LLC · 2016

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K130995 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130995

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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