510(k) · Cleared
ClearedACTION II 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 May 24, 2017 as substantially equivalent to K153229 (Bios S.R.L., 2016) and 1 other predicate after a 190-day review. Its family tree reaches back 18 generations to 1992.
- Decided
- May 24, 2017
- Review
- 190 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K910422 (1992). 360 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations between
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- 1 generation backK153229 SuperbiumBios S.R.L. · 2016
- This deviceK163196 ACTION II Laser SystemLutronic Corporation · 2017
Show all 18 generations
- Root · 18 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 17 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 16 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 15 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 14 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 13 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 12 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 11 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 10 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 9 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 8 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 7 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 6 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 5 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 4 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 3 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 2 generations backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- 1 generation backK153229 SuperbiumBios S.R.L. · 2016
- This deviceK163196 ACTION II Laser SystemLutronic Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −17 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −16 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −15 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −14 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −13 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −12 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −11 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −10 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −9 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −8 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −7 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −6 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −5 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −4 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −3 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K103664 | Primus Aesthetic Platform | Palomar Medical Technologies, Inc. | 2011 | — |
| −1 | K153229 | Superbium | Bios S.R.L. | 2016 | — |
| 0 (this device) | K163196 | ACTION II Laser System | Lutronic Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 17 | 0 |
| 1996 | 23 | 0 |
| 1997 | 24 | 0 |
| 1998 | 21 | 0 |
| 1999 | 13 | 0 |
| 2000 | 25 | 0 |
| 2001 | 28 | 0 |
| 2002 | 38 | 0 |
| 2003 | 31 | 0 |
| 2004 | 20 | 0 |
| 2005 | 17 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K153229 | SuperbiumSummary page 4…Code: GEX, ONG Panel: General and Plastic Surgery 3. Predicate Devices 510(K) Number K153229 K150140 Company Name Bios S.R.L. Asclepion Laser… | 2016 |
| * | K150140 | MCL 31 DermablateSummary page 4…GEX, ONG Panel: General and Plastic Surgery 3. Predicate Devices 510(K) Number K153229 K150140 Company Name Bios S.R.L. Asclepion Laser… | 2015 |
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 25 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 360 ancestors have a recall of any class.
- 1 other device also cites its predicate K153229.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 ACTION II Laser System is indicated for: coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph…
Read the full statement (103 words)
The ACTION II Laser System is indicated for: coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; anal tags; keratoses; scar revision (including acne scars).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163196: ACTION II 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/K163196
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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