510(k) · Cleared
ClearedeCO2 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lutronic Corporation · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Jul 31, 2025 as substantially equivalent to K100610 (Lutronic Corporation, 2011) after a 212-day review. Its family tree reaches back 15 generations to 1992.
- Decided
- Jul 31, 2025
- Review
- 212 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K910422 (1992). 185 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations between
- 3 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 2 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 1 generation backK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- This deviceK244060 eCO2 3DLutronic Corporation · 2025
Show all 15 generations
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 13 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 12 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 11 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 10 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 9 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 8 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 7 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 6 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 5 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 4 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 3 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 2 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 1 generation backK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- This deviceK244060 eCO2 3DLutronic Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −14 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −12 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −11 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −10 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −9 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −8 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −7 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −6 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −5 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −4 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −3 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| −2 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| −1 | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems | Lutronic Corporation | 2011 | — |
| 0 (this device) | K244060 | eCO2 3D | Lutronic Corporation | 2025 | — |
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 |
| 1992 | 1 | 0 |
| 1993 | 6 | 0 |
| 1994 | 14 | 0 |
| 1995 | 11 | 0 |
| 1996 | 14 | 0 |
| 1997 | 14 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 12 | 0 |
| 2002 | 18 | 0 |
| 2003 | 13 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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? (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 |
|---|---|---|---|
| * | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsSummary page 6…878.4810 Product Code(s) GEX, ONG 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Lutronic Corporation eCO2 Plus K100610 (01/20/2011) Predicate SNJ Co. Ltd Finexel K213557 (04/12/2022) Reference 807.92(a)(4) - Device descripti… | 2011 |
| † | K213557 | Finexel | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 185 ancestors have a recall of any class.
- 1 other device also cites its predicate K100610.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The eCO2 3D Laser System with fractional handpieces 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. The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500…
Read the full statement (263 words)
The eCO2 3D Laser System with fractional handpieces 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.
The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry.
Dermatology & Plastic Surgery:
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
* Laser skin resurfacing
* Treatment of wrinkles, rhytids and furrows
* Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.
Dermatology. Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.
Podiatry:
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244060: eCO2 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244060
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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