510(k) · Cleared
ClearedR2 Dermabrasion Tip (for Dermal 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 Aug 5, 2021 as substantially equivalent to K201260 (R2 Technologies, Inc., 2020) after a 308-day review. Its family tree reaches back 12 generations to 2001. 2 later devices descend from it.
- Decided
- Aug 5, 2021
- Review
- 308 days
- Class
- Class II
- Product code
- QPZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K010991 (2001). 32 ancestors in all, the oldest K803311 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 8 generations between
- 3 generations backK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- 2 generations backK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- 1 generation backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- This deviceK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 11 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 10 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 9 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 8 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 7 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 6 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 5 generations backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- 4 generations backK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- 3 generations backK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- 2 generations backK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- 1 generation backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- This deviceK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −11 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −10 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −9 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −8 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −7 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −6 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −5 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| −4 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| −3 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| −2 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| −1 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| 0 (this device) | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| +1 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +2 | 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 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K213294 Dermal Cooling Systemscore 10.9 · 13 generations · no Class I recall
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 |
|---|---|---|---|
| * | K201260 | Dermal Cooling SystemSummary page 4…Code : QPZ, GED Regulation : 21 CFR 878.4340, 21 CFR 878.4800 III. PREDICATE AND REFERENCE DEVICES The predicate device is the Dermal Cooling System, K201260. Name of Device: Dermal Cooling System Common Name: Cryosurgical unit and accessories Regulatory Class:… | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213294 | Dermal Cooling System | 2022 | 1 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 13 of the 32 ancestors have a recall of any class.
- Of its descendants, K213294 (R2 Technologies, Inc., 2022) has gone furthest, with 1 descendant 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. 2021, 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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203006: R2 Dermabrasion Tip (for 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/K203006
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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