Quanta System Youlaser MT
Hybrid Fractional · CO2 10600nm + 1540nm mixed tech
Technology: CO2 Fractional Laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- $90k–$120kSource not documented
- Used asking price
- $45k–$70kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
- Not verified
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Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 4 FDA records
K241092 (Quanta System Spa, 2024)
The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). Surgical Handpieces Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • laser skin resurfacing • laser derm-abrasion • laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Rev02 03/10/2024 OptiScan PRIME Scanner Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K111592 (Quanta System Spa, 2011)
YOULASER CO2 Laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars. The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K123573 (Quanta System Spa, 2013)
YOULASER 002 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER 002 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K182669 (Quanta System Spa, 2018)
The subject device has the same intended use of the unmodified device, as follows: When used in traditional, non-fractionated mode for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing. Performace testing The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances: - IEC 60601-1:2005 + AMD1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. 5-3 - IEC 60601-2-22:2007 + AMD1:2012, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - IEC 60825-1: 2014 Safety of laser products – Part 1: Equipment classification and requirements The subject device passed all the required testing and complies with all applicable sections of the abovementioned standards.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$120k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Quanta System |
|---|---|
| Company | Owner: El.En. Group S.p.A. (Euronext Milan: ELN), 100% (subsidiary, since 2012) · Distribution: via distributor — Astanza Laser (exclusive US distributor from December 1, 2025; previously Cartessa Aesthetics) |
| Parent company | El.En. Group |
| Brand owner | Quanta System |
| Built by (OEM) | Quanta System S.p.A. |
| Category | Hybrid Fractional |
| Technology | CO2 10600nm + 1540nm mixed tech |
| FDA status | FDA Cleared |
| 510(k) citation | K241092, K111592, K123573, K182669 |
| New price range | $90k–$120k |
| Used asking range | $45k–$70k |
| Consumables | Not published |
| Launch year | 2016 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Simultaneous dual-wavelength hybrid resurfacing
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K241092, with family clearances K111592, K123573 and K182669. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K241092 (Quanta System Spa, 2024)
The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). Surgical Handpieces Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: • laser skin resurfacing • laser derm-abrasion • laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Rev02 03/10/2024 OptiScan PRIME Scanner Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K111592 (Quanta System Spa, 2011)
YOULASER CO2 Laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars. The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K123573 (Quanta System Spa, 2013)
YOULASER 002 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER 002 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K182669 (Quanta System Spa, 2018)
The subject device has the same intended use of the unmodified device, as follows: When used in traditional, non-fractionated mode for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing. Performace testing The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances: - IEC 60601-1:2005 + AMD1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. 5-3 - IEC 60601-2-22:2007 + AMD1:2012, Medical Electrical Equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment - IEC 60825-1: 2014 Safety of laser products – Part 1: Equipment classification and requirements The subject device passed all the required testing and complies with all applicable sections of the abovementioned standards.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
CO2 fractional — CO2 10600nm + 1540nm mixed tech
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: El.En. Group
Legal manufacturer: Quanta System S.p.A. (Italy)
Applicant on the FDA record
Quanta System S.p.A.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
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History6 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Quanta System Youlaser MT — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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