510(k) · Cleared
ClearedFractional CO2 Surgical Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ami, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 5, 2018 as substantially equivalent to K111831 (Bio-Med USA, Inc., 2011) and 1 other predicate after a 252-day review. Its family tree reaches back 16 generations to 1992.
- Decided
- Jul 5, 2018
- Review
- 252 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K910422 (1992). 189 ancestors in all, the oldest K820106 (1982). No later device cites it as a predicate yet.
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations between
- 3 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 2 generations backK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- 1 generation backK111831 MX-7000 MicroxelBio-Med USA, Inc. · 2011
- This deviceK173359 Fractional CO2 Surgical Laser SystemAmi, Inc. · 2018
Show all 16 generations
- Root · 16 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 15 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 14 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 13 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 12 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 11 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 10 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 9 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 8 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 7 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 6 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 5 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 4 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 3 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 2 generations backK100610 Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser…Lutronic Corporation · 2011
- 1 generation backK111831 MX-7000 MicroxelBio-Med USA, Inc. · 2011
- This deviceK173359 Fractional CO2 Surgical Laser SystemAmi, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −15 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −14 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −13 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −12 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −11 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −10 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −9 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −8 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −7 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −6 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −5 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −4 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| −3 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| −2 | K100610 | Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser Systems | Lutronic Corporation | 2011 | — |
| −1 | K111831 | MX-7000 Microxel | Bio-Med USA, Inc. | 2011 | — |
| 0 (this device) | 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 |
| 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 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 |
|---|---|---|---|
| * | K111831 | MX-7000 MicroxelSummary page 4…lation Description: Laser Surgical instrument for use in general and plastic surgery and dermatology. Device Class: II Product Code: GEX 2. Predicate Devices K111831 MX-7000 MICROXEL, Dae Shin Enterprises K180036 SMAXEL, IDS, Ltd. 3. Prior Submissions Statement There were no prior subm… | 2011 |
| * | K180036 | SMAXEL CO2 Surgical Laser System Cleared while this submission was under review Summary page 4…se in general and plastic surgery and dermatology. Device Class: II Product Code: GEX 2. Predicate Devices K111831 MX-7000 MICROXEL, Dae Shin Enterprises K180036 SMAXEL, IDS, Ltd. 3. Prior Submissions Statement There were no prior submissions for the BIOXEL Fractional CO2 Surgical Lase… | 2018 |
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 26 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 189 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.
The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173359: Fractional CO2 Surgical 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/K173359
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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