510(k) · Cleared
ClearedMosaic ECO2 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 Jul 7, 2008 as substantially equivalent to K022060 (Lumenis, Inc., 2002) and 4 other predicates after a 136-day review. Its family tree reaches back 12 generations to 1992. 30 later devices descend from it.
- Decided
- Jul 7, 2008
- Review
- 136 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K910422 (1992). 150 ancestors in all, the oldest K820106 (1982). 30 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- This deviceK080496 Mosaic ECO2 Laser SystemLutronic Corporation · 2008
- Descendant · cites it directly · 27 of its ownK091115 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
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- This deviceK080496 Mosaic ECO2 Laser SystemLutronic Corporation · 2008
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K091115ECO2 Laser SystemLutronic Corporation · 2009 · cites it directly27descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −3 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| 0 (this device) | K080496 | Mosaic ECO2 Laser System | Lutronic Corporation | 2008 | — |
| +1 | 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 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…equivalent to the predicate devices, including the Lumenis, Inc. (Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) (K022060); the Sharplan Lasers, Inc. Model 1080 C02 Surgical Laser System (K933918); the Lumenis, Inc. Modified Lumenis Fami… | 2002 |
| * | K933918 | Sharplan Model 1080S CO2 Surgical LaserSummary page 1…UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) (K022060); the Sharplan Lasers, Inc. Model 1080 C02 Surgical Laser System (K933918); the Lumenis, Inc. Modified Lumenis Family of UltraPulse SurgiTouch C02 Laser Systems (KO30 147); the Reliant Tech… | 1994 |
| * | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | 2003 |
| * | K071051 | Fraxel Iii SR Laser System and AccessoriesSummary page 1…s Family of UltraPulse SurgiTouch C02 Laser Systems (KO30 147); the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K07105 1); and the Cynosure, Inc. Smart C02 (K03 1224). 4. Device Description The MOSAIC eCO2 Laser System consists of… | 2007 |
| * | K031224 | SmartxideSummary page 1…ystems (KO30 147); the Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel re:pair) and Accessories (K07105 1); and the Cynosure, Inc. Smart C02 (K03 1224). 4. Device Description The MOSAIC eCO2 Laser System consists of a self-contained console, an articulated… | 2003 |
What descends from it? (30)
See all 304 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 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 5 of the 150 ancestors have a recall of any class.
- Of its descendants, K091115 (Lutronic Corporation, 2009) has gone furthest, with 27 descendants of its own.
- 20 other devices also cite its predicate K022060.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 MOSAIC eCO2 is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. 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/K080496 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080496: Mosaic 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/K080496
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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