510(k) · Cleared
ClearedGlow by Endymed
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 May 8, 2012 as substantially equivalent to K083461 (Endymion Medical, Ltd., 2009) and 1 other predicate after a 77-day review. Its family tree reaches back 17 generations to 1995. 5 later devices descend from it.
- Decided
- May 8, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- OUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 254 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 2 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 deviceK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK121150 Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK201520 The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK233760 Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK160075 Accent XLAlma Lasers, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK141507 Two Skin Treatment SystemSyneron Medical, Ltd. · 2014
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 deviceK120513 Glow by EndymedEndymed Medical, Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc. · 2012 · cites it directly3descendants
- K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc. · 2021 · 2 generations on1descendant
- K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd. · 2024 · 3 generations on0descendants
- K160075Accent XLAlma Lasers, Inc. · 2016 · 2 generations on0descendants
- K141507Two Skin Treatment SystemSyneron Medical, Ltd. · 2014 · cites it directly0descendants
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) | K120513 | Glow by Endymed | Endymed Medical, Ltd. | 2012 | — |
| +1 | K121150 | Alma Lasers Family of Pixel RF Tips | Alma Lasers, Inc. | 2012 | — |
| +2 | K201520 | The Alma Opus System, Colibri Applicator and Tips | Alma Lasers, Inc. | 2021 | — |
| +3 | K233760 | Mjolnir Pro. (Multi–electrode plasma) | Shenzhen Leaflife Technology Co., Ltd. | 2024 | — |
| +2 | K160075 | Accent XL | Alma Lasers, Inc. | 2016 | — |
| +1 | K141507 | Two Skin Treatment System | Syneron Medical, Ltd. | 2014 | — |
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 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 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 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 |
|---|---|---|---|
| * | K083461 | Imagine TC Skin Therapy SystemSummary page 3…he following predicate devices is claimed: Device Name 510k No Date of Clearance EndyMed Imagine TC Skin K083461 Jul 24, 2009 Treatment System EndyMed Fractional Skin Resurfacing (FSR) K1015… | 2009 |
| * | K101510 | Fractional Skin Resurfacing (FSR) ApplicatorSummary page 3…EndyMed Imagine TC Skin K083461 Jul 24, 2009 Treatment System EndyMed Fractional Skin Resurfacing (FSR) K101510 Feb 17, 2011 Applicator ____ _____________ Performance Standards:… | 2011 |
What descends from it? (5)
2 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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 254 ancestors have a recall of any class.
- Of its descendants, K121150 (Alma Lasers, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K083461.
How does its category compare?
All OUH devicesOUH Skin Resurfacing Rf Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures.
The TC applicator is indicated for mild to moderate facial wrinkles and rhytides.
The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
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/K120513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120513: Glow by Endymed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120513
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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