(171 days)
Not Found
No
The document describes a laser device with different wavelengths and handpieces for soft tissue ablation and coagulation. It mentions a graphical user interface and a scanner with a touchscreen for parameter settings and pattern selection. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or automated control beyond basic parameter settings. The performance studies focus on the physical effects of the laser on tissue.
Yes
The device is intended for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue, which are therapeutic actions to treat various conditions like warts, acne scars, and skin resurfacing.
No
The device is described as a medical laser system intended for surgical applications like ablation, vaporization, excision, incision, and coagulation of soft tissue. These are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including laser sources (10600nm and 1550nm), a beam delivery system (articulated arm, handpiece, scanner), a display with a graphical user interface, and a footswitch. The performance studies also involve in vivo testing on animals, which is indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue" in medical specialties like aesthetic surgery (dermatology and plastic surgery). This describes a device used on a patient for treatment, not a device used to test samples from a patient in a laboratory setting.
- Device Description: The description details a medical laser system with different wavelengths, handpieces, and a scanner. This is consistent with a surgical laser device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing diagnostic tests, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to directly treat tissue through laser energy.
N/A
# Intended Use / Indications for 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 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.
# Product codes (comma separated list FDA assigned to the subject device)
GEX
# Device Description
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.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
soft tissue
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
In vivo testing on minipigs was 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.
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60601-2-22, IEC 60825-1, and ISO 10993-1. 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. (sample size: 3 animals). 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. 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.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K203441](https://510k.innolitics.com/search/K203441), [K222221](https://510k.innolitics.com/search/K222221), [K182669](https://510k.innolitics.com/search/K182669)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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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, |