(171 days)
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.
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.
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.
The provided text describes a 510(k) premarket notification for a laser surgical instrument. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a human-in-the-loop or algorithm-only performance study as typically seen for AI/ML-based medical devices.
The "study" mentioned is an in vivo animal study (on minipigs) for the 1550nm fiber laser source to demonstrate safety and effectiveness, specifically regarding its ability to cause ablation and coagulation in tissue. This is a pre-clinical safety/performance study, not a clinical study assessing diagnostic or assistive performance against ground truth and acceptance criteria in the way an AI/ML device would be evaluated.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in the provided document.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance goals for a diagnostic algorithm. The document focuses on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and intended use, and safety and effectiveness through non-clinical (animal) testing.
- Reported Device Performance:
- In vivo minipig study (for 1550nm fiber laser):
- Outcome: "Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days."
- "Re-epithelization was observed three days after radiation in all specimens."
- "Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days."
- "No cases of oedema were observed, and overall, the healing process was uncomplicated."
- "Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation."
- "By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed."
- Conclusion: "The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy." and "The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects."
- In vivo minipig study (for 1550nm fiber laser):
2. Sample sized used for the test set and the data provenance
- Test Set (for the in vivo study): "Three animals were used in this study."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's an in vivo animal study, not human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: Not explicitly stated. The document mentions "histologic analysis performed with H&E staining," which implies expert pathological assessment, but the number and qualifications of the pathologists are not provided.
- Ground truth context: For this type of device, "ground truth" would be the observed biological effects (ablation, coagulation, healing) in the animal tissue, as assessed histologically.
4. Adjudication method for the test set
- Not applicable/Not mentioned, as this was an evaluation of physical effects on tissue, not a diagnostic decision process requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This type of study is for AI-assisted diagnostic devices. The Youlaser PRIME is a laser surgical instrument, and the evaluation presented is a non-clinical (animal) study of its physical effects, not a human-reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/algorithm-only device. The "study" refers to the laser's physical interaction with tissue.
7. The type of ground truth used
- For the in vivo animal study: Histology results (e.g., H&E staining at various time points) examining ablation, coagulation, and re-epithelialization in minipig skin tissue.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model.
Summary of Device and its Evaluation:
The Youlaser PRIME family devices are laser surgical instruments. The "study" mentioned in the document is an in vivo non-clinical study on minipigs designed to demonstrate the safety and effectiveness of the 1550nm fiber laser source by evaluating the biological response (ablation, coagulation, healing) in animal tissue. This type of evaluation is standard for surgical devices that interact directly with tissue, focusing on physical parameters and biological outcomes rather than diagnostic performance or human-AI interaction. The document's primary purpose is to establish substantial equivalence to legally marketed predicate devices, which is achieved by comparing technical specifications and demonstrating comparable safety and effectiveness through non-clinical testing.
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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.
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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).
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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
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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.
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510(k) Summary
K241092
| Applicant /Manufacturerand address: | Quanta System S.p.A., Via Acquedotto 109, 21017Samarate (VA), Italy |
|---|---|
| Contact person: | Dario BandieraRA ManagerQuanta System S.p.A.Email: dario.bandiera@quantasystem.comPhone: +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 andplastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Predicate devices: | The Alma Hybrid Laser System (K203441), DekaHelix (K222221), Youlaser CO2 (K182669) |
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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 LaserSystem | Deka Helix | Youlaser CO2 | |
| (K number) | K241092 | K203441 | K222221 | K182669 | -- |
| Manufacturer | Quanta System S.p.A. | Alma Lasers, Ltd. | El.En ElectronicEngineering Spa | Quanta SystemS.p.A. | -- |
| Product Code | GEX | GEX, ONG | GEX, ONG | GEX | Identical |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| LaserClassification | II | II | II | II | Identical |
| UserInterface | Touch-screen displayEmergency ButtonKey Switch | Touch-screen displayEmergency ButtonKey Switch | Touch-screen displayEmergency ButtonKey Switch | Touch-screendisplayEmergency ButtonKey Switch | Identical |
| LaserWavelength | $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 @10600nmUp to 15W @1550nm | Up to 70W @10600nmUp to 15W @1570nm | Up to 70W @10600nmUp to 14.4W @1570nm | Up to 30W@10600nm | Within therange ofpredicatedevices |
| Aiming beam | 630 - 650 nm, <5mW,Class 3R | 650nm, 3mW | 635nm, 4mW | 650nm, < 4 mW,Class 3R | Within therange of thepredicatedevices |
| 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 | |||||
| Beamdelivery | Articulated arm | Articulated arm | Articulated arm | Articulated arm | Identical |
| System | |||||
| Power Supply | 100-240 VAC, 50/60 Hz | 120 VAC, 11 A, 50/60 Hz, | 100-230 V, 16A 50/60 Hz | 115 Vac; 50/60 Hz | Differences do |
| single phase | or 230 Vac; 50/60 | not | |||
| 220/230 VAC, 6 A, 50/60 | Hz | affect safety | |||
| Hz, single phase | and | ||||
| effectiveness | |||||
| Dimensions | 564x570x1252 mm | 465x533x1345/1973mm | 620x630x1380/1020 mm | 580x460x 1330 mm | Differences do |
| (erected) | (erected) | (erected) | (erected) | not | |
| affect safety | |||||
| andeffectiveness | |||||
| Weight | 130Kg | 86Kg | 70Kg | 55Kg | Differences do |
| not | |||||
| affect safety | |||||
| and | |||||
| effectiveness | |||||
| Part in | Stainless Steel AISI 316L | Data not available | Data not available | Stainless Steel AISI | Identical |
| contact with | 316L | ||||
| patient - | |||||
| Material | |||||
| Handpieces – Non fractionalSpot Size | Surgical Handpieces | HyLight CO2 | CO2 Handpieces | Surgical Handpieces | Within the |
| (mm) | • 0.150 - 2 mm | • 0.15 – 3 mm @50mm | • 0.125 – 2.0 mm | • 0.200 – 1 mm | range of the |
| working distance | predicate | ||||
| • 0.25 – 3.1 mm | devices | ||||
| @200mm working | |||||
| distance | |||||
| Frequency | @10600nm | 1-100 Hz @10600nm | 0.2 - 200 Hz @10600nm | @10600nm | Within the |
| 0.5-200 Hz: Up to 50W | Up to 1000 Hz /CW | range of the | |||
| 0.5-995 Hz/CW: Up to | predicate | ||||
| 30W | devices. | ||||
| Pulse | 5μs-1000ms @10600nm | 1-1000ms @10600nm | 10 - 900ms @10600nm | up to 80ms | Differences do |
| Duration | @10600nm | not | |||
| affect safety | |||||
| and | |||||
| effectiveness | |||||
| Fluence | Max 2830 J/mm2 @50W | Max 3530 J/mm2 @70W | Within the | ||
| range of the | |||||
| predicatedevice | |||||
| Scanning Unit - Fractional | |||||
| Spot Size | OptiScan PRIME | ProScan CO2 | Scanning Unit | Optiscan | Differences do |
| @10600nm and | spot size @10600nm: | spot size @10600nm: | Spot size | not | |
| @1550nm: | 0.35mm @100 mm | 0.374mm | @10600nm: | affect safety | |
| Spot size: 0.250mm | distance | spot size @1570nm: | 0.300mm | and | |
| Scan size: up to | ProScan 1570 | 0.75mm | Scan size: up to | effectiveness: | |
| 18x18mm | spot size @1570nm: | scan size @1570nm: | 18x18mm | Discussion 2 | |
| 0.75mmscan size @1570nm: | 20x20mm | ||||
| Up to 30 mm diameter | |||||
| Max Output | @10600nm: | @10600nm: | @10600nm: | @10600nm: | Discussion 2 |
| Energy | 122mJ | 240 mJ | 251mJ | 60mJ | |
| @1550nm: | @1570 nm: | @1570 nm: | |||
| 80 mJ | 144 mJ/pixel | 144mJ | |||
| @mixed emission10600nm+1550nm:75mJ + 80mJ | |||||
| frequency | Up to 1Hz | Data not available | Data not available | Data not available | According toour in vivostudy:Discussion 2 |
| Beam Density@10600nm | 80% - 98% untreatedtissue between spotsUp to 400 (dot/cm2) | ~63% - 97% untreatedtissue between spots | 61% - 98% untreatedtissue between spots | Up to 400(dot/cm2) | Same ofpredicateYoulaser CO2.Safercondition foruntreatedtissue:Discussion 2 |
| Beam Density@1550 nm | 80% - 98% untreatedtissue between spotsUp to 400 (dot/cm2) | Up to 390 pixels/cm2 | Up to 400 pixels/cm2 | Same ofpredicateDeka Helix.Safercondition foruntreatedtissue:Discussion 2 | |
| Intended Use | The Youlaser PRIMEfamily laser devices(Youlaser PRIME,Youlaser PRIME CO2,Youlaser PRIME MT) andaccessories are intendedfor use in surgicalapplications requiringthe ablation,vaporization, excision,incision, and coagulationof soft tissue in medicalspecialties including:aesthetic surgery(dermatology and plasticsurgery).Surgical HandpiecesYoulaser PRIME CO2,Youlaser PRIME andYoulaser PRIME MT witha wavelength of10600nm used incombination withsurgical handpieces areindicated for use for theparticular indications asfollows:Dermatology & PlasticSurgeryThe ablation,vaporization, excision,incision, and coagulationof soft tissue indermatology and plasticsurgery in theperformance of: | The Alma Hybrid LaserSystem, Delivery Devices,Applicators andAccessories are intendedfor use in surgicalapplications requiringthe ablation,vaporization, excision,incision, and coagulationof soft tissue in medicalspecialties including:aesthetic surgery(dermatology and plasticsurgery).HyLight-CO2The Alma Hybrid CO2non-fractionalapplicator, withwavelength of 10600 nmis cleared for use for theparticular indications asfollows:Dermatology & PlasticSurgeryThe ablation,vaporization, excision,incision, and coagulationof soft tissue indermatology and plasticsurgery in theperformance of:*laser skin resurfacing*laser derm-abrasion*laser burndebridement.Laser skin resurfacing | The Helix Laser Systemwith its accessories isintended for use insurgical applicationsrequiring the ablation,vaporization, excision,incision, and coagulationof soft tissue in medicalspecialties including:aesthetic surgery(dermatology and plasticsurgery).CO2 HandpiecesThe Helix CO2handpieces withwavelength of 10600 nmare indicated for use forthe particular indicationsas follows:Dermatology & PlasticSurgeryThe ablation,vaporization, excision,incision, and coagulationof soft tissue indermatology and plasticsurgery in theperformance of:* laser skin resurfacing* laser derm-abrasion* laser burndebridement.Laser skin resurfacing(ablation and/orvaporization) of softtissue for the reduction, | YOULASER CO2laser when used intraditional, non-fractionated modefor:Incision, excision,ablation,vaporization andcoagulation of bodysoft tissuesincluding intraoraltissues, in medicalspecialties includingaesthetic(dermatology andplastic surgery),otorhinolaryngology(ENT), gynaecology,neurosurgery,dental and oralsurgery andgenitourinarysurgery.YOULASER CO2laser when used infractionated mode(scanner) isindicated only forablative skinresurfacing. | Same of AlmaHybrid andDeka Helix. |
Table 1: Main specifications comparison table.
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| * laser derm-abrasion* laser burndebridement.Laser skin resurfacing(ablation and/orvaporization) of softtissue for the reduction,removal, and/ortreatment of: warts,acne scars, neviepidermal, syringoma.Vaporization/coagulationof warts. | vaporization) of softtissue for the reduction,removal, and/ortreatment of: warts,acne scars, neviepidermal, syringoma.Vaporization/coagulationof warts.PixelThe Alma Hybrid PixelCO2 fractionalapplicator, withwavelength of 10600 nmis indicated for: Theablation, vaporization,and coagulation of softtissue in dermatologyand plastic surgery in theperformance of skinresurfacing.ProScanThe Alma Hybrid ProScanCO2 fractionalapplicator, withwavelength of 10600 nmis indicated for:•Laser skin resurfacing(ablation and/orvaporization) of softtissue.The Alma Hybrid ProScan1570nm fractionalapplicator, withwavelength of 1570 nm,is indicated for:• Use in dermatologicalprocedures requiringfractional skinresurfacing andcoagulation of soft tissueThe Alma Hybrid ProScanCO2 &1570nm fractionalapplicator, withwavelengths of 10600nm & 1570nm isindicated for laser skinresurfacing (ablationand/or vaporization) ofsoft tissue. | treatment of: warts,acne scars, neviepidermal, syringoma.Vaporization/coagulationof warts.Scanning unitThe Helix Scanning unit,with wavelength of10600 nm is indicatedfor:•Laser skin resurfacing(ablation and/orvaporization) of softtissueThe Helix Scanning unit,with wavelength of 1570nm, is indicated for:• Use in dermatologicalprocedures requiringfractional skinresurfacing andcoagulation of soft tissueThe Helix Scanning unit,with wavelengths of10600 nm & 1570nm isindicated for laser skinresurfacing (ablationand/or vaporization) ofsoft tissue. |
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Discussion 1
The laser wavelength of this device is similar to K203441 and K222221.
According to the laser absorption curve of human tissues, the wavelength range from 1500nm to 1600nm belongs to the main absorption of water, while absorption by other components is minimum. Therefore, the subtle wavelength difference between 1550nm and 1570nm will not have any difference in the penetration depth of laser and the absorption effect of tissues, and will not affect the clinical effectiveness.
Discussion 2
The Youlaser PRIME family devices integrate a CO2 laser source at 10600nm and a fiber laser source at 1550nm, both of which are analyzed in terms of their safety and efficacy for clinical skin treatments. The
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accessory OptiScan is used in combination with the device for delivering the laser radiation to the patient. It receives the laser radiation from the laser device (CO2, Erbium Fiber Laser or mixed) as a uniform spot and delivers it to the skin tissue in the form of patterns of different shape and dimension. The fractional grid patterns are substantially equivalent to the predicate devices with differences regarding spot size and beam density.
Despite these differences, the maximum energy level for the 10600mm source, which is limited to 122ml, when compared to the stated spot size, ensures an equal fluence level between the compared devices. Since the depth of ablation is directly related to the energy levels delivered, the safety of the treatment in terms of depth of ablation and extent of thermal damage can be considered comparable.
Another key aspect is the micro spot density setting, which is limited to 400 dots/cm². This spot density value generates a pattern of ablative and thermal lesions with a pitch of approximately 500μm, but with a wider distance respect to the predicates. This configuration results in a pattern of ablative and thermal lesions that leave untreated skin between the treated areas, promoting faster healing and minimizing discomfort.
The Fiber Laser Source (1550nm) follows a similar strategy, with a maximum energy level of 80mJ, verified through in vivo testing on minipigs.
Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days. Three animals were used in this study.
Re-epithelization was observed three days after radiation in all specimens. Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days. No cases of oedema were observed, and overall, the healing process was uncomplicated.
Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation. By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed.
The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy.
The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects.
Indication for use 4
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, 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, 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.
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OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600mm 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.
Non-clinical tests 5
The present device was subject to non-clinical testing according to the following standards (Table 2):
| Standard |
|---|
| IEC 60601-1:2005/AC 1:2006/A1:2012/AC1:2014/AMD2:2020Medical electrical equipment - Part 1: General requirements for basic safety and essentialperformance |
| IEC 60601-1-2:2014; IEC 60601-1-2:2014/A1:2020Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6: 2010/AMD1: 2013 Collateral standard: Usability |
| IEC 62366-1: 2015/COR1: 2016 Part 1: Application of usability engineering to medical devices |
| IEC 62304: 2006/AMD1: 2015 Medical device software (SW) |
| IEC 60601-2-22: 2019 Particular requirements for basic safety and essential performance ofsurgical, cosmetic etc. |
| IEC 60825-1: 2014 Safety of laser products – Part 1: Equipment classification and requirements |
| ISO 10993-1: 2018 Biological evaluation of medical devices |
Table 2: Applied standards.
In addition, in vivo testing on minipigs and histological analysis were performed to demonstrate safety and effectiveness of the Fiber Laser Source (1550nm), with a maximum energy level of 80mJ. Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days. Three animals were used in this study.
The results of the non-clinical performance testing support that the subject device can be used safely and effectively.
Substantial equivalence discussion 6
Youlaser PRIME family devices have intended use of the predicate devices and comparable technical specifications.
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7 Conclusions
Non-clinical tests conducted support that the devices can be used safely and effectively for the proposed indications for use. The differences in technological characteristics between the subject and predicate devices do not raise new questions regarding safety and effectiveness for the proposed indications for use. Thus, the subject device is considered to be substantially equivalent to the predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.