510(k) · Cleared
ClearedECO2 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · GEX Powered Laser Surgical Instrument
Cleared on Oct 30, 2009 as substantially equivalent to K080496 (Lutronic Corporation, 2008) and 5 other predicates after a 196-day review. Its family tree reaches back 13 generations to 1992. 27 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 196 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K910422 (1992). 153 ancestors in all, the oldest K820106 (1982). 27 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 1 generation backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- This deviceK091115 ECO2 Laser SystemLutronic Corporation · 2009
- Descendant · cites it directly · 19 of its ownK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · 2 generations on · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- Descendant · 3 generations on · 10 of its ownK170325 Secret RFIlooda Co,., Ltd. · 2017
- Descendant · 4 generations on · 3 of its ownK210084 SilkroHironic Co., Ltd. · 2022
- Descendant · 4 generations on · 3 of its ownK180654 PINXEL-RF systemRohrer Aesthetics, LLC · 2018
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 4 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 1 generation backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- This deviceK091115 ECO2 Laser SystemLutronic Corporation · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K123573Youlaser CO2 LaserQuanta System Spa · 2013 · cites it directly19descendants
- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · 2 generations on14descendants
- K170325Secret RFIlooda Co,., Ltd. · 2017 · 3 generations on10descendants
- K210084SilkroHironic Co., Ltd. · 2022 · 4 generations on3descendants
- K180654PINXEL-RF systemRohrer Aesthetics, LLC · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −4 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −3 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −2 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −1 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| 0 (this device) | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| +1 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +2 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| +3 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
| +4 | K210084 | Silkro | Hironic Co., Ltd. | 2022 | — |
| +4 | K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 13 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 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 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? (6)
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 |
|---|---|---|---|
| * | K080496 | Mosaic ECO2 Laser SystemSummary page 1…t Code: GEX Panel: General & Plastic Surgery 3. Predicate Devices The eCO2 is a modification of the eCO2 cleared in K080496. The indications for use are exactly the same as the cleared eCO2. Additionally, the eCO2 is substantially equivalent… | 2008 |
| * | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesSummary page 1…d eCO2. Additionally, the eCO2 is substantially equivalent to the the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K080915); the Lasering SLIM Evolution Family of C02 Lasers with Mixto SX Scanner (K063001); Lumenis, Inc. Active FX and Deep… | 2008 |
| * | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesSummary page 1…nologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K080915); the Lasering SLIM Evolution Family of C02 Lasers with Mixto SX Scanner (K063001); Lumenis, Inc. Active FX and Deep FX UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories… | 2007 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…Lasers with Mixto SX Scanner (K063001); Lumenis, Inc. Active FX and Deep FX UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060 and K030147); and the Cynosure, Inc. Smart C02 (K031224). 4. Device Description The eCO2 Laser System c… | 2002 |
| * | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersSummary page 1…Mixto SX Scanner (K063001); Lumenis, Inc. Active FX and Deep FX UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060 and K030147); and the Cynosure, Inc. Smart C02 (K031224). 4. Device Description The eCO2 Laser System consists of a… | 2003 |
| * | K031224 | SmartxideSummary page 1…FX and Deep FX UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060 and K030147); and the Cynosure, Inc. Smart C02 (K031224). 4. Device Description The eCO2 Laser System consists of a self-contained console, an articulated arm del… | 2003 |
What descends from it? (27)
See all 273 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 7 companies; a new generation was cleared every 10 months on median.
- 5 of the 153 ancestors have a recall of any class.
- Of its descendants, K123573 (Quanta System Spa, 2013) has gone furthest, with 19 descendants of its own.
- 3 other devices also cite its predicate K080496.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The eCO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091115: ECO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091115
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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