510(k) · Cleared
ClearedEdgeOne CO2 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeisys Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 27, 2016 as substantially equivalent to K100590 (Jm System Co., Ltd., 2010) and 1 other predicate after an 85-day review. Its family tree reaches back 19 generations to 1995. 7 later devices descend from it.
- Decided
- Oct 27, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K943450 (1995). 356 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 3 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK113504 Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 2013
- 1 generation backK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
- This deviceK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK201109 CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK221597 CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK241670 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser…Beijing Adss Development Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK260974 CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250465 CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd. · 2025
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 2 generations backK113504 Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 2013
- 1 generation backK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
- This deviceK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · cites it directly5descendants
- K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022 · 2 generations on2descendants
- K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd. · 2024 · 3 generations on1descendant
- K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd. · 2026 · 2 generations on0descendants
- K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −2 | K113504 | Deka Smartxide and Delivery Accessories | El.En Electronic Engineering Spa | 2013 | — |
| −1 | K133895 | Deka Smartxide Laser System | El.En S.P.A. | 2014 | — |
| 0 (this device) | K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016 | — |
| +1 | K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +2 | K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | 2022 | — |
| +3 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy… | Beijing Adss Development Co., Ltd. | 2024 | — |
| +2 | K260974 | CO2 Laser Machine (Monica-I,Monica-II) | Nanjing Bestview Laser S&T Co., Ltd. | 2026 | — |
| +1 | K250465 | CO2 Laser Machine (Lume) | Nanjing Bestview Laser S&T Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 23 | 0 |
| 1995 | 20 | 0 |
| 1996 | 26 | 0 |
| 1997 | 27 | 0 |
| 1998 | 24 | 0 |
| 1999 | 18 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 34 | 0 |
| 2003 | 29 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K100590 | Edge CO2 Laser SystemSummary page 4…Primary Classification Names: Surgical Powered Light Instrument, III. Predicate Devices K# Predicate Device K100590 EDGE CO2 LASER SYSTEM K133895 DEKA SMARTXIDE LASER SYSTEM IV. Product Description… | 2010 |
| * | K133895 | Deka Smartxide Laser SystemSummary page 4…ed Light Instrument, III. Predicate Devices K# Predicate Device K100590 EDGE CO2 LASER SYSTEM K133895 DEKA SMARTXIDE LASER SYSTEM IV. Product Description The Jeisys EdgeOne CO2 Laser is comprised of the… | 2014 |
What descends from it? (7)
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 21 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 16 of the 356 ancestors have a recall of any class.
- Of its descendants, K201109 (Shanghai Apolo Medical Technology Co., Ltd., 2020) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K100590.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162169: EdgeOne CO2 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162169
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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