← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K241092 # Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (K241092) _Quanta System Spa · GEX · Oct 10, 2024 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K241092 ## Device Facts - **Applicant:** Quanta System Spa - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Oct 10, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use 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 Handbieces 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. 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. ## Device Story Youlaser PRIME family consists of medical laser systems emitting 10600nm (CO2) and 1550nm (fiber) wavelengths; used for soft tissue surgery. Input: user-selected parameters via GUI/touchscreen; laser emission triggered by external footswitch. Transformation: RF-driven sealed gas tube (CO2) or fiber laser source delivers energy via articulated arm to surgical handpiece or OptiScan PRIME scanner. Output: laser radiation for ablation, vaporization, excision, incision, or coagulation. Used in clinical settings (dermatology/plastic surgery) by physicians. Scanner delivers fractional grid patterns to skin; CO2 provides ablation, 1550nm provides coagulation. Clinical benefit: precise tissue removal/coagulation with controlled thermal damage, promoting faster healing and minimized discomfort compared to traditional methods. ## Clinical Evidence Bench testing per IEC 60601-1, 60601-1-2, 60601-1-6, 62366-1, 62304, 60601-2-22, 60825-1, and ISO 10993-1. In vivo study on 3 minipigs evaluated 1550nm fiber laser (max 80mJ). Histology (H&E staining) at 0-14 days showed predictable ablation/coagulation, re-epithelization by day 3, and full healing by day 14. No edema observed; transient erythema noted as primary side effect. ## Technological Characteristics Laser sources: 10600nm (RF-driven CO2) and 1550nm (fiber). Delivery: articulated arm with handpieces or OptiScan PRIME scanner. Materials: Stainless Steel AISI 316L in patient contact. Connectivity: GUI/touchscreen interface. Power: 100-240 VAC. Software: IEC 62304 compliant. Sterilization: Not specified. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - The Alma Hybrid Laser System ([K203441](/device/K203441.md)) - Deka Helix ([K222221](/device/K222221.md)) - Youlaser CO2 ([K182669](/device/K182669.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 10, 2024 Quanta System S.p.A. Dario Bandiera Regulatory Affairs Manager Via Acquedotto 109 Samarate, VA 21017 Italy Re: K241092 Trade/Device Name: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: September 12, 2024 Received: September 12, 2024 Dear Dario Bandiera: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). {2}------------------------------------------------ Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by TANISHA TANISHA L. HITHE -S L. HITEE-C Date: 2024.10.10 2017年10月10日 --> 23:28:14 -04'00' Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) ### K241092 Device Name Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT Indications for Use (Describe) 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 Handbieces 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. ## 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) Summary # K241092 | Applicant /
Manufacturer
and address: | Quanta System S.p.A., Via Acquedotto 109, 21017
Samarate (VA), Italy | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Contact person: | Dario Bandiera
RA Manager
Quanta System S.p.A.
Email: dario.bandiera@quantasystem.com
Phone: +39-0331-376797 | | Date Prepared: | 03/10/2024 | | Trade/device name: | Youlaser PRIME,
Youlaser PRIME CO2,
Youlaser PRIME MT | | Classification: | Class II | | Classification Name: | Laser surgical instrument for use in general and
plastic surgery and in dermatology. | | Regulation Number: | 21 CFR 878.4810 | | Product Code: | GEX | | Predicate devices: | The Alma Hybrid Laser System (K203441), Deka
Helix (K222221), Youlaser CO2 (K182669) | {6}------------------------------------------------ ## 1 Abbreviations FW= firmware GUI= graphical user interface SW= software #### Device description 2 The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations. The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum. The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm). The beam delivery system is an articulated arm with a handpiece or a scanner on its end. The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings). The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,...etc. Laser emission is controlled via the external footswitch has an activation pedal which enables laser emission. #### Comparison with the predicate 3 In Table 1, the main specifications of the subject device are summarized and compared to the predicates: | Specification | Subject Device | Predicate 1 | Predicate 2 | Predicate 3 | Comments | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Device Name | Youlaser PRIME MT,
Youlaser PRIME,
Youlaser PRIME CO2 | The Alma Hybrid Laser
System | Deka Helix | Youlaser CO2 | | | (K number) | K241092 | K203441 | K222221 | K182669 | -- | | Manufacturer | Quanta System S.p.A. | Alma Lasers, Ltd. | El.En Electronic
Engineering Spa | Quanta System
S.p.A. | -- | | Product Code | GEX | GEX, ONG | GEX, ONG | GEX | Identical | | Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical | | Laser
Classification | II | II | II | II | Identical | | User
Interface | Touch-screen display
Emergency Button
Key Switch | Touch-screen display
Emergency Button
Key Switch | Touch-screen display
Emergency Button
Key Switch | Touch-screen
display
Emergency Button
Key Switch | Identical | | Laser
Wavelength | $10.6 \mu m \pm 0.4\mu m$
$1550nm \pm 1nm$ | $10.6 \mu m$
$1570nm$ | $10.6 \mu m \pm 0.4\mu m$
$1570nm \pm 10nm$ | $10.6 \mu m \pm 0.4\mu m$ | Discussion 1 | | Power | Up to 50W @10600nm
Up to 15W @1550nm | Up to 70W @10600nm
Up to 15W @1570nm | Up to 70W @10600nm
Up to 14.4W @1570nm | Up to 30W
@10600nm | Within the
range of
predicate
devices | | Aiming beam | 630 - 650 nm, <5mW,
Class 3R | 650nm, 3mW | 635nm, 4mW | 650nm, < 4 mW,
Class 3R | Within the
range of the
predicate
devices | | Emission | Footswitch | Footswitch | Footswitch | Footswitch | Identical | | Control | Interlock | Interlock | Interlock | Interlock | | | Delivery | Surgical Handpieces and | Handpieces and scanner | Handpieces and scanner | Surgical Handpieces | Differences do | | devices | scanner (OptiScan | (HyLight Applicators, | (CO2 handpieces, | and scanner | not | | | PRIME) | Pixel Applicators, | CO2/1570nm Scanning | (OptiScan) | affect safety | | | | ProScan) | unit) | | and | | | | | | | effectiveness | | Beam
delivery | Articulated arm | Articulated arm | Articulated arm | Articulated arm | Identical | | System | | | |… --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K241092](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K241092) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com