510(k) · Cleared
ClearedAGNES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gowoonsesang Cosmetics Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 5, 2017 as substantially equivalent to K881276 (Ime Co., Ltd., 1988) and 1 other predicate after a 321-day review. Its family tree reaches back 12 generations to 1995. 9 later devices descend from it.
- Decided
- Jan 5, 2017
- Review
- 321 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 9 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 2 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 1 generation backK153727 INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016
- This deviceK160469 AGNESGowoonsesang Cosmetics Co., Ltd. · 2017
- Descendant · cites it directly · 6 of its ownK192728 AgnesAgnes Medical Co., Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK203013 AGNESAgnes Medical Co., Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK223805 AgnesAgnes Medical Co., Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK242469 RFMagik LiteAgnes Medical Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK241832 Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I)…Boston Aesthetics, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK072261 Finesse SystemPrimaeva Medical, Inc. · 2007
- 4 generations backK080145 Primaeva Medical SystemPrimaeva Medical, Inc. · 2008
- 3 generations backK082391 Primaeva Medical Renesis SystemPrimaeva Medical, Inc. · 2009
- 2 generations backK121481 Infini Radiofrequency SystemLutronic Corporation · 2013
- 1 generation backK153727 INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 2016
- This deviceK160469 AGNESGowoonsesang Cosmetics Co., Ltd. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K192728AgnesAgnes Medical Co., Ltd. · 2019 · cites it directly6descendants
- K203013AGNESAgnes Medical Co., Ltd. · 2022 · 2 generations on4descendants
- K223805AgnesAgnes Medical Co., Ltd. · 2023 · 3 generations on3descendants
- K242469RFMagik LiteAgnes Medical Co., Ltd. · 2025 · 4 generations on2descendants
- K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc. · 2025 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K072261 | Finesse System | Primaeva Medical, Inc. | 2007 | — |
| −4 | K080145 | Primaeva Medical System | Primaeva Medical, Inc. | 2008 | — |
| −3 | K082391 | Primaeva Medical Renesis System | Primaeva Medical, Inc. | 2009 | — |
| −2 | K121481 | Infini Radiofrequency System | Lutronic Corporation | 2013 | — |
| −1 | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System | Jeisys Medical, Inc. | 2016 | — |
| 0 (this device) | K160469 | AGNES | Gowoonsesang Cosmetics Co., Ltd. | 2017 | — |
| +1 | K192728 | Agnes | Agnes Medical Co., Ltd. | 2019 | — |
| +2 | K203013 | AGNES | Agnes Medical Co., Ltd. | 2022 | — |
| +3 | K223805 | Agnes | Agnes Medical Co., Ltd. | 2023 | — |
| +4 | K242469 | RFMagik Lite | Agnes Medical Co., Ltd. | 2025 | — |
| +1 | K241832 | Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF… | Boston Aesthetics, Inc. | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K881276 | HR-5000 Electrosurgical Device for New IndicationsSummary page 4…INTRAcel Premium Fractional HR-5000 RF Micro Needle (FRM) System 510(k) number K153727 K881276 5. Description AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The acce… | 1988 |
| * | K153727 | INTRAcel Premium Fractional RF Micro Needle (FRM) System Cleared while this submission was under review Summary page 4…IME Co., Ltd. Device Name INTRAcel Premium Fractional HR-5000 RF Micro Needle (FRM) System 510(k) number K153727 K881276 5. Description AGNES is a RF electrosurgical device. It consists of LCD screen, radiofreq… | 2016 |
What descends from it? (9)
3 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 22 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K192728 (Agnes Medical Co., Ltd., 2019) has gone furthest, with 6 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. 2017, 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/K160469 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160469: AGNES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160469
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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