510(k) · Cleared
ClearedR2 Dermal Cooling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Dermatology · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 5, 2016 as substantially equivalent to K110754 (Cryopen, Inc., 2011) and 1 other predicate after a 127-day review. Its family tree reaches back 9 generations to 2001. 5 later devices descend from it.
- Decided
- Oct 5, 2016
- Review
- 127 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010991 (2001). 24 ancestors in all, the oldest K803311 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 5 generations between
- 3 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 2 generations backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- 1 generation backK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- This deviceK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · cites it directly · 4 of its ownK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- Descendant · 2 generations on · 3 of its ownK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · 5 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 8 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 7 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 6 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 5 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 4 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 3 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 2 generations backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- 1 generation backK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- This deviceK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
Most influential descendants
Showing 5 of 5 · See all- K171398Dermal Cooling SystemR2 Dermatology,Inc · 2017 · cites it directly4descendants
- K201260Dermal Cooling SystemR2 Technologies, Inc. · 2020 · 2 generations on3descendants
- K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021 · 3 generations on2descendants
- K213294Dermal Cooling SystemR2 Technologies, Inc. · 2022 · 4 generations on1descendant
- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −8 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −7 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −6 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −5 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −4 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −3 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −2 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| −1 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| 0 (this device) | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +1 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| +2 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| +3 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| +4 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +5 | K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K110754 | Cryopen Cryosurgical System, K102214Summary page 4…CFR 878.4350) Regulatory Class: II Product Code: GEH III. PREDICATE DEVICE The primary predicate device is the CryoPen® Surgical System, K110754. The secondary predicate device is the Galil Medical Visual-Ice® Cryoablation System, K152133. IV. DEVICE DESCRIPTION The R2 De… | 2011 |
| * | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Summary page 4…ICATE DEVICE The primary predicate device is the CryoPen® Surgical System, K110754. The secondary predicate device is the Galil Medical Visual-Ice® Cryoablation System, K152133. IV. DEVICE DESCRIPTION The R2 Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogen… | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171398 | Dermal Cooling System | 2017 | 4 |
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 2 companies; a new generation was cleared every 1.4 years on median.
- 12 of the 24 ancestors have a recall of any class.
- Of its descendants, K171398 (R2 Dermatology,Inc, 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 R2 Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161480: R2 Dermal Cooling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161480
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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