510(k) · Cleared
ClearedXLase Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotec Italia, Srl · GEX Powered Laser Surgical Instrument
Cleared on Aug 15, 2022 as substantially equivalent to K192539 (El.En Electronic Engineering Spa, 2019) after a 348-day review. Its family tree reaches back 23 generations to 1995.
- Decided
- Aug 15, 2022
- Review
- 348 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 23 generations to K943450 (1995). 550 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 2 generations backK152714 Quanta ForteQuanta System Spa · 2015
- 1 generation backK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- This deviceK212790 XLase PlusBiotec Italia, Srl · 2022
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 10 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 9 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 6 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 5 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 4 generations backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- 3 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 2 generations backK152714 Quanta ForteQuanta System Spa · 2015
- 1 generation backK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- This deviceK212790 XLase PlusBiotec Italia, Srl · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −10 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −9 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −6 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −5 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −4 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| −3 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| −2 | K152714 | Quanta Forte | Quanta System Spa | 2015 | — |
| −1 | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
| 0 (this device) | K212790 | XLase Plus | Biotec Italia, Srl | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 10 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 27 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 31 | 0 |
| 1999 | 27 | 0 |
| 2000 | 35 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 35 | 0 |
| 2005 | 30 | 0 |
| 2006 | 17 | 0 |
| 2007 | 18 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 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? (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 |
|---|---|---|---|
| * | K192539 | Deka LuxeaSummary page 6…XLase Plus Traditional 510(k) K212790 Trade Name: Deka Luxea 510k - K192539 El., EN. Electronic Engineering SPA Via Baldanzese 17 Calenzano, IT 50041 VI. REFERENCE DEV… | 2019 |
| † | K193367 | elysion-pro | 2020 |
| † | K053628 | Lightsheer Duet Laser System | 2006 |
| † | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | 2015 |
| † | K201111 | GentleMax Pro Plus | 2020 |
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 27 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 28 of the 550 ancestors have a recall of any class.
- 3 other devices also cite its predicate K192539.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
XLase Plus is indicated for use as follows: Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. * Treatment of Pseudofolliculitis barbae (PFB) * Use on all skin types (Fitzpatrick I-VI).…
Read the full statement (537 words)
XLase Plus is indicated for use as follows:
Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
* Treatment of Pseudofolliculitis barbae (PFB)
* Use on all skin types (Fitzpatrick I-VI).
SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins.
Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions.
CPL Handpiece: Indicated for use Fitzpatrick skin types I — IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions.
Pulsed light Hair reduction Benign Blood vessels Benign
Wavelength range Vascular lesions Pigmented lesions
500-1200nm - Skin Types [, 11 Skin Types [, 11 -
520-1200nm - SkinType 111 Skin Type 11 Skin Types I, 11
550-1200nm Skin Types I, 11 - - Skin Type Il
595-1200nm Skin Type I - - -
650-1200nm Skin Type [V - - Skin Type IV
ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece.
Diode 2800W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin. Indicated for:
- the treatment of benign vascular and benign pigmented lesions,
- permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Diode 1200W 810nm Handpiece:
Indicated for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin.
Indicated for the treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae.
Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indicated for the treatment of benign pigmented lesions and leg veins.
ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I- VI) including tanned skin.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212790: XLase Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212790
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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