510(k) · Cleared
ClearedMtone Evo (Mtone Evo)
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 Sep 20, 2024 after a 200-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 20, 2024
- Review
- 200 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
MTONE EVO 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. MTONE EVO with HR808nm and HR808 XL Laser Handpieces are indicated for the treatment of benign vascular lesions, benign pigmented lesions, lhair removal and permanent hair reduction*. MTONE EVO with HR760/808/1060nm Laser Handpiece is indicated…
Read the full statement (522 words)
MTONE EVO 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.
MTONE EVO with HR808nm and HR808 XL Laser Handpieces are indicated for the treatment of benign vascular lesions, benign pigmented lesions, lhair removal and permanent hair reduction*.
MTONE EVO with HR760/808/1060nm Laser Handpiece is indicated for Benign vascular and vascular dependent lesions removal (VL mode: freqiuency < 9 Hz) and temporary hair reduction (HR In-moving mode: frequency > = 9 Hz)
MTONE EVO with AC415-950nm Intense Pulsed Li\1ht (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (1-V) to the Fitzpatrick scale.
MTONE EVO 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 (1-V) to the Fitzpatrick scale.
MTONE EVO 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 erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).
MTONE EVO with HR580-950 nm Intense Pulsed Liight (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (1-V) to the Fitzpatrick scale.
MTONE EVO with SR580-950 nm Intense Pulsed Liight (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.
MTONE EVO with HR635-950 nm Intense Pulsed Liight (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent: hair reduction* in all skin types (1-V) to the Fitzpatrick scale.
MTONE EVO with HR635-950 nm Intense Pulsed Liight (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated to Hair removal and permanent Hair reduction in all skin types (1-V) to the Fitzpatrick scale.
MTONE EVO 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).
MTONE EVO 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.
MTONE EVO with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:
«» Benign vascular and pigmented lesions, age spots
* Nevus spilus
» Tattoo removal
MTONE EVO 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240604: Mtone Evo (Mtone Evo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240604
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026