510(k) · Cleared
ClearedEndyMed PRO MAX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endymed Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 10, 2025 as substantially equivalent to K083461 (Endymion Medical, Ltd., 2009) and 3 other predicates after a 257-day review. Its family tree reaches back 21 generations to 1995. 1 later device descends from it.
- Decided
- Jun 10, 2025
- Review
- 257 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K943450 (1995). 355 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations between
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK161199 EndyMed Contour HandpieceEndymed Medical, Ltd. · 2016
- This deviceK242996 EndyMed PRO MAXEndymed Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251836 Dermatrix DuoShenzhen Gsd Technology Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 16 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 15 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 14 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 13 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 10 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 9 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 8 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 7 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 6 generations backK082876 Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd. · 2008
- 5 generations backK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- 4 generations backK133837 Viora V-TotalViora, Ltd. · 2014
- 3 generations backK142093 V20 SystemViora, Ltd. · 2014
- 2 generations backK150035 V10 systemViora, Ltd. · 2015
- 1 generation backK161199 EndyMed Contour HandpieceEndymed Medical, Ltd. · 2016
- This deviceK242996 EndyMed PRO MAXEndymed Medical, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −20 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −16 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −15 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −14 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −13 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −10 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −9 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −8 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −7 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −6 | K082876 | Beamax/ Formax Pulsed Light Device Family | Sharplight Technologies, Ltd. | 2008 | — |
| −5 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| −4 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| −3 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| −2 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
| −1 | K161199 | EndyMed Contour Handpiece | Endymed Medical, Ltd. | 2016 | — |
| 0 (this device) | K242996 | EndyMed PRO MAX | Endymed Medical, Ltd. | 2025 | — |
| +1 | K251836 | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 10 | 0 |
| 1992 | 4 | 0 |
| 1993 | 9 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 22 | 0 |
| 1997 | 23 | 0 |
| 1998 | 22 | 0 |
| 1999 | 14 | 0 |
| 2000 | 26 | 0 |
| 2001 | 28 | 0 |
| 2002 | 33 | 0 |
| 2003 | 28 | 0 |
| 2004 | 16 | 0 |
| 2005 | 15 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (4)
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 5….4400 Product Code GEI, OUH, PBX Regulatory Class II Legally Marketed Imagine TC Skin Therapy System (K083461) Predicate/Reference Devices Intensif Applicator (K130501) EndyMed Contour Handpi… | 2009 |
| * | K161199 | EndyMed Contour HandpieceSummary page 5…ine TC Skin Therapy System (K083461) Predicate/Reference Devices Intensif Applicator (K130501) EndyMed Contour Handpiece (K161199) EndyMed FSR Applicator (K101510) Device Description: ENDYMED PRO™ MAX is a computerized s… | 2016 |
| * | K130501 | IntensifSummary page 5…y Class II Legally Marketed Imagine TC Skin Therapy System (K083461) Predicate/Reference Devices Intensif Applicator (K130501) EndyMed Contour Handpiece (K161199) EndyMed FSR Appl… | 2014 |
| * | K101510 | Fractional Skin Resurfacing (FSR) ApplicatorSummary page 5…Intensif Applicator (K130501) EndyMed Contour Handpiece (K161199) EndyMed FSR Applicator (K101510) Device Description: ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emi… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251836 | Dermatrix Duo | 2026 | 0 |
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 9 companies; a new generation was cleared every 9 months on median.
- 13 of the 355 ancestors have a recall of any class.
- Of its descendants, K251836 (Shenzhen Gsd Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K083461.
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 PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece. The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to…
Read the full statement (166 words)
The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece.
The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242996: EndyMed PRO MAX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242996
Report an extraction error
Are you the manufacturer?
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