510(k) · Cleared
ClearedDermal Cooling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Technologies, Inc. · QPZ Contact Cooling For Skin Lesion Pain Relief
Cleared on Nov 10, 2022 as substantially equivalent to K203006 (R2 Technologies, Inc., 2021) and 1 other predicate after a 405-day review. Its family tree reaches back 13 generations to 2001. 1 later device descends from it.
- Decided
- Nov 10, 2022
- Review
- 405 days
- Class
- Class II
- Product code
- QPZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K010991 (2001). 71 ancestors in all, the oldest K803311 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 9 generations between
- 3 generations backK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- 2 generations backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- 1 generation backK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- This deviceK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 12 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 11 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 10 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 9 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 8 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 7 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 6 generations backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- 5 generations backK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- 4 generations backK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- 3 generations backK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- 2 generations backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- 1 generation backK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- This deviceK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K253261Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −12 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −11 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −10 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −9 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −8 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −7 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −6 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| −5 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| −4 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| −3 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| −2 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| −1 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| 0 (this device) | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +1 | 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 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 QPZ? 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 QPZ device
- #1 K203006 R2 Dermabrasion Tip (for Dermal Cooling System)score 8.1 · 12 generations · no Class I recall
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 |
|---|---|---|---|
| * | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System)Summary page 4…QPZ, GED, ILO Regulation: 21 CFR 878.4340, 21 CFR 878.4800, 21 CFR 890.5720 III. PREDICATE The primary predicate device is the Dermal Cooling System, K203006. The secondary predicate device is the COOLSKIN device, K083008. IV. DEVICE DESCRIPTION The Dermal Cooling System is identical… | 2021 |
| * | K083008 | CoolskinSummary page 4…CFR 878.4800, 21 CFR 890.5720 III. PREDICATE The primary predicate device is the Dermal Cooling System, K203006. The secondary predicate device is the COOLSKIN device, K083008. IV. DEVICE DESCRIPTION The Dermal Cooling System is identical to the device cleared in K203006. The Dermal Cooling System is a… | 2009 |
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 |
|---|---|---|---|
| K253261 | Apollo Quattro (APQ-10M) | 2026 | 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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 71 ancestors have a recall of any class.
- Of its descendants, K253261 (Weero Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QPZ devicesQPZ Contact Cooling For Skin Lesion Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QPZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QPZ
Too few QPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QPZ
No recall names QPZ since 2007.
Adverse event reports per year · QPZ
No MAUDE report names QPZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical…
Read the full statement (110 words)
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.
When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal.
The Dermal Cooling System is intended to be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213294: 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/K213294
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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