510(k) · Cleared
ClearedClaritag Advanced
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dgi Technologies · GEH Unit, Cryosurgical, Accessories
Cleared on May 18, 2023 as substantially equivalent to K211099 (Cryoconcepts LP, 2022) and 1 other predicate after a 287-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- May 18, 2023
- Review
- 287 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K881349 (1988). 13 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK222356 Claritag AdvancedDgi Technologies · 2023
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) | K222356 | Claritag Advanced | Dgi Technologies | 2023 | — |
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 |
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? (2)
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…: May 17, 2023 Device Class: II Regulation Name and Number: 878.4350 Panel: Office of Health Technology 4, Division of Health Technology 4 A Product Code: GEH Predicate: K211099 Device Description The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag rem… | 2022 |
| * | K190747 | ClaritagSummary page 7…y DGI Technologies Dr. Scholl's ) Characteristic K222356 K211099 K190747 Intended Use Skin Tags Warts & Skin Tags Skin Tags OTC… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 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. 2023, 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 Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222356: Claritag Advanced.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222356
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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