510(k) · Cleared
ClearedFreezpoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bovie Medical Corp. · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 21, 2018 as substantially equivalent to K102006 (Stc Consulting, LLC, 2010) after a 55-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Mar 21, 2018
- Review
- 55 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024009 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K102006 | CryomegaSummary page 5…‘˜‹†‡†‹–Š‡ˆ‘ŽŽ‘™‹‰–ƒ„Ž‡Ǥ Technological Freezpoint Predicate Characteristics CryOmega-K102006 –‡†‡†•‡ǣŠ‡ –‡†‡†•‡ǣŠ‡ -Intended Use ”‡‡œ‡’‘‹–‹•ƒ… | 2010 |
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 15 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K102006.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Freezpoint device is intended for the surgical destruction of tissue of target tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Plantaris
• Genital Lesions
• Seborrheic Keratosis
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/K180211 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180211: Freezpoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180211
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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