510(k) · Cleared
ClearedMT One
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M&T S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Apr 24, 2020 as substantially equivalent to K110907 (Palomar Medical Technologies, Inc., 2011) and 7 other predicates after a 203-day review. Its family tree reaches back 23 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 24, 2020
- Review
- 203 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 23 generations to K943450 (1995). 574 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 2 citing it directly.
- 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 backK172413 MT ONEM&T S.R.L. · 2017
- This deviceK192856 MT OneM&T S.R.L. · 2020
- Descendant · cites it directly · 1 of its ownK203395 Platform treatment systemShanghai Apolo Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK240474 Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd · 2024
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 backK172413 MT ONEM&T S.R.L. · 2017
- This deviceK192856 MT OneM&T S.R.L. · 2020
Most influential descendants
Showing 2 of 2 · See allView 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 | K172413 | MT ONE | M&T S.R.L. | 2017 | — |
| 0 (this device) | K192856 | MT One | M&T S.R.L. | 2020 | — |
| +1 | K203395 | Platform treatment system | Shanghai Apolo Medical Technology Co., Ltd. | 2022 | — |
| +1 | K240474 | Multi-function Platform Systems (BL-M10) | Shanghai Bele Medical Technology Co.,Ltd | 2024 | — |
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 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 11 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 28 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 34 | 0 |
| 1999 | 29 | 0 |
| 2000 | 36 | 0 |
| 2001 | 36 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 35 | 0 |
| 2005 | 32 | 0 |
| 2006 | 17 | 0 |
| 2007 | 20 | 0 |
| 2008 | 21 | 0 |
| 2009 | 11 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 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? (8)
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 |
|---|---|---|---|
| * | K110907 | Palomar Icon (TM) Aesthetic SystemSummary page 5…(IPL) and laser System Class I Laser surgical instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810 GEX, ONG, ONF, ONE Icon - PALOMAR - K110907 Quanta Forte - QUANTA SYSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - K… | 2011 |
| * | K152714 | Quanta ForteSummary page 5…al instrument for use in general and plastic surgery and in dermatology 21 CFR 878.4810 GEX, ONG, ONF, ONE Icon - PALOMAR - K110907 Quanta Forte - QUANTA SYSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One… | 2015 |
| * | K111303 | Dermatological Treatment Device FamilySummary page 5…and in dermatology 21 CFR 878.4810 GEX, ONG, ONF, ONE Icon - PALOMAR - K110907 Quanta Forte - QUANTA SYSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K1611… | 2011 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 |
| * | K142860 | Lumenis M22 SystemSummary page 5…R - K110907 Quanta Forte - QUANTA SYSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550 FOR NORDLYS- ELLIPSE A/S 5-1 Via della Fiera, 8… | 2015 |
| * | K172413 | MT ONESummary page 5…QUANTA SYSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550 FOR NORDLYS- ELLIPSE A/S 5-1 Via della Fiera, 87 - ‘ij‘i T… | 2017 |
| * | K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Summary page 5…YSTEM SPA - K152714 OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550 FOR NORDLYS- ELLIPSE A/S 5-1 Via della Fiera, 87 - ‘ij‘i T ONE M&T… | 2015 |
| * | K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Summary page 5…ax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303 Harmony X| - ALMA LASERS LTD. - KO72564 M22 - LUMENIS LTD. - K142860 MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550 FOR NORDLYS- ELLIPSE A/S 5-1 Via della Fiera, 87 - ‘ij‘i T ONE M&T s.r.l. | Via della Fiera,… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 companies; a new generation was cleared every 10 months on median.
- 31 of the 574 ancestors have a recall of any class.
- Of its descendants, K203395 (Shanghai Apolo Medical Technology Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K110907.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
MT ONE and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery. MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*. MT ONE with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without…
Read the full statement (485 words)
MT ONE and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.
MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.
MT ONE with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.
MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of benign Pigmented and Vascular Lesions in skin types (I-V) to the Fitzpatrick scale.
MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) with Sub-Millisecond Technology (S.M.T.) is indicated for the treatment of erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).
MT ONE with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.
MT ONE with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.
MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.
MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated Hair removal and permanent Hair reduction in all skin types (I-VI) to the Fitzpatrick scale
MT ONE with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:
Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
MT ONE with 1064 nm Long Pulse (LP) Nd:YAG Laser Handpiece is indicated for:
• Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation)
• Treatment of pseudofolliculitis barbae (PFB)
• Benign vascular Lesions.
* Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:
• Benign vascular and pigmented lesions, age spots
• Nevus spilus
• Tattoo removal
MT ONE with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for
• Post-operative Scars, Acne Scars, Skin Resurfacing, Striae
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/K192856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192856: MT One.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192856
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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