510(k) · Cleared
ClearedAgnes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agnes Medical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on May 4, 2023 as substantially equivalent to K203013 (Agnes Medical Co., Ltd., 2022) after a 136-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- May 4, 2023
- Review
- 136 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK160469 AGNESGowoonsesang Cosmetics Co., Ltd. · 2017
- 2 generations backK192728 AgnesAgnes Medical Co., Ltd. · 2019
- 1 generation backK203013 AGNESAgnes Medical Co., Ltd. · 2022
- This deviceK223805 AgnesAgnes Medical Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK242469 RFMagik LiteAgnes Medical Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK250217 AGNES UltraAgnes Medical Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243713 Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E…Agnes Medical Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 7 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 6 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 5 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 4 generations backK153727 INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016
- 3 generations backK160469 AGNESGowoonsesang Cosmetics Co., Ltd. · 2017
- 2 generations backK192728 AgnesAgnes Medical Co., Ltd. · 2019
- 1 generation backK203013 AGNESAgnes Medical Co., Ltd. · 2022
- This deviceK223805 AgnesAgnes Medical Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K242469RFMagik LiteAgnes Medical Co., Ltd. · 2025 · cites it directly2descendants
- K250217AGNES UltraAgnes Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −7 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −6 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −5 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −4 | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016 | — |
| −3 | K160469 | AGNES | Gowoonsesang Cosmetics Co., Ltd. | 2017 | — |
| −2 | K192728 | Agnes | Agnes Medical Co., Ltd. | 2019 | — |
| −1 | K203013 | AGNES | Agnes Medical Co., Ltd. | 2022 | — |
| 0 (this device) | K223805 | Agnes | Agnes Medical Co., Ltd. | 2023 | — |
| +1 | K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | 2025 | — |
| +2 | K250217 | AGNES Ultra | Agnes Medical Co., Ltd. | 2025 | — |
| +2 | K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S… | Agnes Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K203013 | AGNESSummary page 4…n: GEI, 21CFR 878.4400 - Subsequent Product Code and Regulation: KCW, 21CFR 878.5350 - Device Class: II 2. Predicate Device - Agnes, K203013 3. Description AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and… | 2022 |
| † | K171707 | GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A | 2017 |
| † | K102372 | Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models GBS-DM, GBS-DB | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242469 | RFMagik Lite | 2025 | 2 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K242469 (Agnes Medical Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223805: Agnes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223805
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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