510(k) · Cleared
ClearedIntensif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endymed Medical, Ltd. · OUH Skin Resurfacing Rf Applicator
Cleared on Mar 13, 2014 as substantially equivalent to K080145 (Primaeva Medical, Inc., 2008) and 2 other predicates after a 379-day review. Its family tree reaches back 17 generations to 1995. 57 later devices descend from it.
- Decided
- Mar 13, 2014
- Review
- 379 days
- Class
- Class II
- Product code
- OUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K943450 (1995). 256 ancestors in all, the oldest K800617 (1980). 57 later devices descend from it, 4 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 2 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 1 generation backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- This deviceK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · cites it directly · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
- Descendant · 2 generations on · 16 of its ownK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- Descendant · 3 generations on · 15 of its ownK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
- Descendant · cites it directly · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 5 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 4 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 3 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 2 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 1 generation backK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- This deviceK130501 IntensifEndymed Medical, Ltd. · 2014
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · cites it directly38descendants
- K192545PotenzaJeisys Medical Incorporated · 2020 · 2 generations on20descendants
- K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019 · 2 generations on16descendants
- K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020 · 3 generations on15descendants
- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −5 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −4 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −3 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −2 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −1 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| 0 (this device) | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +1 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +2 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
| +2 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD, Ltd. | 2019 | — |
| +3 | K200947 | InMode System with the Morhpeus8 Applicators | InMode, Ltd. | 2020 | — |
| +1 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 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 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 23 | 0 |
| 2002 | 28 | 0 |
| 2003 | 23 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 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 OUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080145 | Primaeva Medical SystemSummary page 2…lowing predicate devices is claimed: Device Name 510(k) No Date of Clearance Primaeva Medical System K080 145 Feb 28, 2008 EndyMed FSR K101510 Feb 17, 2011 EndyMed Imagine TC Ski… | 2008 |
| * | K101510 | Fractional Skin Resurfacing (FSR) ApplicatorSummary page 2…510(k) No Date of Clearance Primaeva Medical System K080 145 Feb 28, 2008 EndyMed FSR K101510 Feb 17, 2011 EndyMed Imagine TC Skin K083461 Jul124, 2009 Treatment System… | 2011 |
| * | K083461 | Imagine TC Skin Therapy SystemSummary page 2…K080 145 Feb 28, 2008 EndyMed FSR K101510 Feb 17, 2011 EndyMed Imagine TC Skin K083461 Jul124, 2009 Treatment System __________ __________ Performance Standards:… | 2009 |
What descends from it? (57)
See all 574 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 256 ancestors have a recall of any class.
- Of its descendants, K180189 (Inmode MD, Ltd., 2018) has gone furthest, with 38 descendants of its own.
- 3 other devices also cite its predicate K080145.
How does its category compare?
All OUH devicesOUH Skin Resurfacing Rf Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OUH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OUH
Too few OUH 510(k)s in any year since 2007 to give a median.
Recalls per year · OUH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUH
3in 2025
MAUDE reports naming product code OUH, 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 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IntensjfApplkcator is intended for use in Dermatalogic and General Surgical procedures for electrocoagulation and heinostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130501: Intensif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130501
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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