510(k) · Cleared
ClearedNew Doublo 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hironic Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 29, 2025 as substantially equivalent to K233123 (Hironic Co., Ltd., 2024) and 1 other predicate after a 152-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Sep 29, 2025
- Review
- 152 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 22 generations to K943450 (1995). 317 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK170325 Secret RFIlooda Co,., Ltd. · 2017
- 2 generations backK210084 SilkroHironic Co., Ltd. · 2022
- 1 generation backK233123 SilkroHironic Co., Ltd. · 2024
- This deviceK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 10 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 9 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 8 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 7 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 6 generations backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- 5 generations backK130501 IntensifEndymed Medical, Ltd. · 2014
- 4 generations backK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- 3 generations backK170325 Secret RFIlooda Co,., Ltd. · 2017
- 2 generations backK210084 SilkroHironic Co., Ltd. · 2022
- 1 generation backK233123 SilkroHironic Co., Ltd. · 2024
- This deviceK251334 New Doublo 2.0Hironic Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −10 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −9 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −8 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −7 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −6 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| −5 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| −4 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| −3 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
| −2 | K210084 | Silkro | Hironic Co., Ltd. | 2022 | — |
| −1 | K233123 | Silkro | Hironic Co., Ltd. | 2024 | — |
| 0 (this device) | K251334 | New Doublo 2.0 | Hironic Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 15 | 0 |
| 1996 | 23 | 0 |
| 1997 | 22 | 0 |
| 1998 | 15 | 0 |
| 1999 | 12 | 0 |
| 2000 | 23 | 0 |
| 2001 | 24 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K233123 | SilkroSummary page 5…ss ll Review Panel General & Plastic Surgery (ODE) 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed Primary Predicate K233123 Device SILKRO Predicate/Reference K241099 Device PLASONIC 807.92(a)(4) – Device Descri… | 2024 |
| * | K241099 | Plasonic (Plasonic)Summary page 5…DE) 807.92(a)(3) – Legally marketed device(s) to which equivalence is claimed Primary Predicate K233123 Device SILKRO Predicate/Reference K241099 Device PLASONIC 807.92(a)(4) – Device Description This device is an instrument used for tissue coagulation by… | 2024 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 317 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The NEW DOUBLO 2.0 with RM and RM(B) handpiece is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
The NEW DOUBLO 2.0 with PS handpiece is intended for the removal and destruction of skin lesions and coagulation of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251334 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251334: New Doublo 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251334
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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