510(k) · Cleared
ClearedCryomega
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stc Consulting, LLC · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 6, 2010 as substantially equivalent to K024009 (H&O Equipments, Nv/Sa, 2003) after an 82-day review. Its family tree reaches back 1 generation to 2003. 8 later devices descend from it.
- Decided
- Oct 6, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024009 (2003). 8 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK024009 CryoprobeH&O Equipments, Nv/Sa · 2003
- This deviceK102006 CryomegaStc Consulting, LLC · 2010
- Descendant · cites it directly · 6 of its ownK172769 CryOmega FlexxCryoconcepts LP · 2017
- Descendant · 2 generations on · 5 of its ownK203481 CryoVIVERecensmedical, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK220674 TargetCoolRecensmedical, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK221234 TargetCoolRecensmedical, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK230599 TargetCool™Recensmedical, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172769CryOmega FlexxCryoconcepts LP · 2017 · cites it directly6descendants
- K203481CryoVIVERecensmedical, Inc. · 2021 · 2 generations on5descendants
- K220674TargetCoolRecensmedical, Inc. · 2022 · 3 generations on4descendants
- K221234TargetCoolRecensmedical, Inc. · 2022 · 4 generations on3descendants
- K230599TargetCool™Recensmedical, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024009 | Cryoprobe | H&O Equipments, Nv/Sa | 2003 | — |
| 0 (this device) | K102006 | Cryomega | Stc Consulting, LLC | 2010 | — |
| +1 | K172769 | CryOmega Flexx | Cryoconcepts LP | 2017 | — |
| +2 | K203481 | CryoVIVE | Recensmedical, Inc. | 2021 | — |
| +3 | K220674 | TargetCool | Recensmedical, Inc. | 2022 | — |
| +4 | K221234 | TargetCool | Recensmedical, Inc. | 2022 | — |
| +3 | K230599 | TargetCool™ | Recensmedical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K024009 | CryoprobeSummary page 1…. IEauitanialc I Crvourobe-C ri nencnec use: To0 The crvumega is. a I IK024009 Idestroy tissue Idisposable- device I -±-ntendeca Use-… | 2003 |
What descends from it? (8)
2 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?
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 CryOmega is a disposable device intended for the surgical destruction of
target tissue by applying cryogenic gases at extreme low temperatures. The list
below shows examples of the type of lesions that can be treated.
-Genital Lesions
-Molluscumn Contagiosum
-Seborrheic Keratoses
-Skin Tags
-Verruca Plantaris
-Verruca Vulgaris
-Verruca Plana
-Actinic Keratosis
-Lentigo
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102006: Cryomega.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102006
Report an extraction error
Are you the manufacturer?
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