510(k) · Cleared
ClearedMX-7000 Microxel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Med USA, Inc. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Dec 19, 2011 as substantially equivalent to K100610 (Lutronic Corporation, 2011) and 1 other predicate after a 174-day review. Its family tree reaches back 15 generations to 1992. 1 later device descends from it.
- Decided
- Dec 19, 2011
- Review
- 174 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K910422 (1992). 187 ancestors in all, the oldest K820106 (1982). 1 later device descends from it, 1 citing it directly.
- 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 deviceK111831 MX-7000 MicroxelBio-Med USA, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK173359 Fractional CO2 Surgical Laser SystemAmi, Inc. · 2018
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 deviceK111831 MX-7000 MicroxelBio-Med USA, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K173359Fractional CO2 Surgical Laser SystemAmi, Inc. · 2018 · cites it directly0descendants
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) | K111831 | MX-7000 Microxel | Bio-Med USA, Inc. | 2011 | — |
| +1 | K173359 | Fractional CO2 Surgical Laser System | Ami, Inc. | 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 |
| 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 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (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 |
|---|---|---|---|
| * | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsSummary page 1…: II Product Code : ONG Subsequent product code : GEX 4. Legally marketed Predicate Device K100610 eCO2 Plus Laser Lutronic K100590 Edge C02 Laser, SM Systems 5. Device Description… | 2011 |
| * | K100590 | Edge CO2 Laser SystemSummary page 1…ONG Subsequent product code : GEX 4. Legally marketed Predicate Device K100610 eCO2 Plus Laser Lutronic K100590 Edge C02 Laser, SM Systems 5. Device Description MIX-7000 Laser system utilize a Co2 module to gene… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173359 | Fractional CO2 Surgical Laser System | 2018 | 0 |
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 19 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 5 of the 187 ancestors have a recall of any class.
- Of its descendants, K173359 (Ami, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 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. 2011, 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?
MX-7000 C02 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.
When used in fractionated mode, the MX-7000 C02 system is intended to be used for ablative skin re-surfacing, Wrinkle, Fine lines, Ryhlides,
Furrow in Dermatology, in Plastic surgery, and in General surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111831: MX-7000 Microxel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111831
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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