510(k) · Cleared
ClearedApollo Quattro (APQ-10M)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weero Co., Ltd. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Mar 13, 2026 as substantially equivalent to K212253 (Weero Co., 2022) and 1 other predicate after a 165-day review. Its family tree reaches back 14 generations to 2001.
- Decided
- Mar 13, 2026
- Review
- 165 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K010991 (2001). 77 ancestors in all, the oldest K803311 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 10 generations between
- 3 generations backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- 2 generations backK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- 1 generation backK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- This deviceK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
Show all 14 generations
- Root · 14 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 13 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 12 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 11 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 10 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 9 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 8 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 7 generations backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- 6 generations backK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- 5 generations backK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- 4 generations backK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- 3 generations backK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- 2 generations backK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- 1 generation backK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- This deviceK253261 Apollo Quattro (APQ-10M)Weero Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −13 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −12 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −11 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −10 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −9 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −8 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −7 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| −6 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| −5 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| −4 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| −3 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| −2 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| −1 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 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 |
|---|---|---|---|
| * | K212253 | Apollo Duet (Model : APD-4000)Summary page 5…Device 510(k) No. Primary Predicate Device WEERO Co.,Ltd. Apollo Duet (Model : APD-4000) K212253 Secondary Predicate Device R2 Technologies, Inc. Dermal Cooling System K213294 4. Descr… | 2022 |
| * | K213294 | Dermal Cooling SystemSummary page 5…Apollo Duet (Model : APD-4000) K212253 Secondary Predicate Device R2 Technologies, Inc. Dermal Cooling System K213294 4. Description of the Device Apollo Quattro is a combination stimulator used to relieve pain by applying radio frequency,… | 2022 |
| † | K042301 | Protens Electrode | 2004 |
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 25 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 77 ancestors have a recall of any class.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
Q-LF handpiece, Q-FX handpiece, Q-SC handpiece, and Q-BT handpiece in RF mode are intended for:
Relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.
Q-EP handpiece in cooling mode is intended for:
Use in dermatologic procedures for the removal of benign lesions of the skin and for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253261 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253261: Apollo Quattro (APQ-10M).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253261
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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