510(k) · Cleared
ClearedPixie Skin Tag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oystershell NV · ORE (no longer in FDA’s product-code list)
Cleared on Oct 18, 2024 as substantially equivalent to K211099 (Cryoconcepts LP, 2022) after a 266-day review. Its family tree reaches back 5 generations to 1988. 1 later device descends from it.
- Decided
- Oct 18, 2024
- Review
- 266 days
- Product code
- ORE
- 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 deviceK240226 Pixie Skin TagOystershell NV · 2024
- 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) | K240226 | Pixie Skin Tag | Oystershell NV | 2024 | — |
| +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 ORE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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…er: 21 CFR 878.4350 Product Code: ORE (Cryogenic Skin Tag Removal, OTC) Device Class: Class II 3. PREDICATE DEVICE K211099 CryoConcepts Freeze'n Clear Skin Clinic Warts & Tags, Regulation 21 CFR 878.4350, Product Code GEH REFERENCE… | 2022 |
| † | K172373 | Compound W Nitro-Freeze | 2017 |
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 36 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.
What is it indicated for?
Pixie® Skin Tag is a cryogenic device for home use intended to treat skin tags in persons over the age of 21.
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/K240226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240226: Pixie Skin Tag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240226
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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