510(k) · Cleared
ClearedFractional Skin Resurfacing (FSR) Applicator
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 Feb 17, 2011 as substantially equivalent to K073572 (Syneron Medical, Ltd., 2008) and 1 other predicate after a 261-day review. Its family tree reaches back 16 generations to 1995. 64 later devices descend from it.
- Decided
- Feb 17, 2011
- Review
- 261 days
- Class
- Class II
- Product code
- OUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K943450 (1995). 253 ancestors in all, the oldest K800617 (1980). 64 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 2 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 1 generation backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- This deviceK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · cites it directly · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 2 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · 3 generations on · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
- Descendant · 3 generations on · 16 of its ownK192695 InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019
- Descendant · 4 generations on · 15 of its ownK200947 InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 4 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 3 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 2 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 1 generation backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- This deviceK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K130501IntensifEndymed Medical, Ltd. · 2014 · cites it directly57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 2 generations on38descendants
- K192545PotenzaJeisys Medical Incorporated · 2020 · 3 generations on20descendants
- K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd. · 2019 · 3 generations on16descendants
- K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd. · 2020 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −4 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −3 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −2 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −1 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| 0 (this device) | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +1 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +2 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +3 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
| +3 | K192695 | InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD, Ltd. | 2019 | — |
| +4 | K200947 | InMode System with the Morhpeus8 Applicators | InMode, Ltd. | 2020 | — |
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 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 16 | 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? (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 |
|---|---|---|---|
| * | K073572 | Matrix RF ApplicatorSummary page 2…lence to the following predicate devices is claimed: Device Name 510k No Date of Clearance Syneron Matrix RF K(073572 Sep 17, 2008 Applicator _____ ______________ EndyMed Imagine TC Skin K… | 2008 |
| * | K083461 | Imagine TC Skin Therapy SystemSummary page 2…ron Matrix RF K(073572 Sep 17, 2008 Applicator _____ ______________ EndyMed Imagine TC Skin K(083461 Jul 24, 2009 Treatment System _____ ______________ Performance Standards:… | 2009 |
What descends from it? (64)
See all 645 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 16 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 253 ancestors have a recall of any class.
- Of its descendants, K130501 (Endymed Medical, Ltd., 2014) has gone furthest, with 57 descendants of its own.
- 4 other devices also cite its predicate K073572.
How does its category compare?
All OUH devicesOUH Skin Resurfacing Rf Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101510: Fractional Skin Resurfacing (FSR) Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101510
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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