InnoVoyce VYLO

K240159 · Innovoyce · GEX · May 29, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K240159
• Device Name: InnoVoyce VYLO
• Applicant: Innovoyce
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 29, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coaqulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include: General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids). Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaqinal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids. Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis. Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. Ophthalmology: Post-vitrectomy endophotocoaqulation of the retina. Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures. Spinal Surgery: Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures. Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).

Device Story

InnoVoyce VYLO is a solid-state diode laser (445-465nm) for soft tissue surgery. System comprises base console with touchscreen, footswitch, and sterile, single-use laser optical fibers (300, 400, 600 microns). Operated by specialized physicians/authorized personnel in healthcare facilities. Laser energy delivered via fiber to target tissue; enables incision, excision, vaporization, ablation, hemostasis, and coagulation. Supports continuous, pulsed, quasi-pulsed, and quasi-continuous wave modes. Output settings adjusted via UI. Provides controlled thermal damage profiles for surgical procedures; benefits include precise tissue management and hemostasis.

Clinical Evidence

No clinical studies conducted. Bench testing only. Comparative histology study on liver, kidney, and muscle tissue demonstrated VYLO produces consistent, detectable coagulation and ablation zones comparable to the predicate device at similar power levels (30W).

Technological Characteristics

Solid-state diode laser; 445-465nm wavelength; 30W max power; Class 4 laser. Features touchscreen interface, internal cooling, and single-use optical fibers (300-600µm). Operates in CW, PW, QPW, and QCW modes. Complies with IEC 60601-1, 60601-1-2, 60601-2-22, and IEC 60825-1 standards.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue (skin, muscle, organs, glands, etc.) in general, GI, gynecological, ENT, neurosurgical, ophthalmic, plastic, thoracic, and urological procedures, including BPH treatment in men.

Regulatory Classification

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

• Greenlight XPS Laser System (K092735)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is stacked, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" in a slightly smaller font, and "ADMINISTRATION" in the smallest font.

May 29, 2024

InnoVoyce % Thompson Aubrey Regulatory Consultant Hoy and Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825

Re: K240159

Trade/Device Name: InnoVoyce VYLO 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: April 25, 2024 Received: April 25, 2024

Dear Thompson Aubrey:

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/cdrh/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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 QS 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.

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-devices/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed Tanisha L. by Tanisha L. Hithe -S Hithe -S Date: 2024.05.29 23:22:25 -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)

K240159

Device Name

InnoVoyce VYLO

### Indications for Use (Describe)

The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coaqulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:

General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).

Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaqinal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.

Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.

Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.

Ophthalmology:

Post-vitrectomy endophotocoaqulation of the retina.

Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.

Spinal Surgery: Percutaneous lumbar diskectomy.

Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.

Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).

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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)

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| Applicant | InnoVoyce, LLC |
|-----------------------------------|----------------------------------------------------------------------------|
| Address | One Beacon Street, Floor 15<br>Boston, MA 02108 |
| Sponsor Contact | Stephen Mais<br>[e-mail] |
| Regulatory Contact | Aubrey Thompson, Regulatory Consultant<br>[e-mail] |
| Preparation Date | May 22, 2024 |
| Device Trade Name | InnoVoyce VYLO |
| K Number | K240159 |
| Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 878.4810 |
| Product Code | GEX |
| Regulatory Class | II |
| Legally Marketed Predicate Device | Greenlight XPS Laser System<br>K092735 |

### Device Description:

InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm.

The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments.

### Indications for use:

The InnoVoyce VYLO is intended for the surgical incision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:

General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract;

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### 510(K) Summary InnoVovce VYI ()

esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastric erosions); gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).

Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.

Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.

Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.

Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.

Plastic Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue in endoscopic and open procedures.

Spinal Surgery: Percutaneous lumbar diskectomy.

Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.

Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia/ hypoplasia (BPH).

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Device Comparison – Indications for use and Technical Specifications:

| Specification | Subject Device | Predicate Device - Greenlight XPS Laser | Comparison |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K240159 | System (K092735) | |
| Indications for use | The InnoVoyce VYLO is intended for the<br>surgical incision/excision,<br>vaporization, ablation, hemostasis and<br>coagulation of soft tissue. All soft tissue<br>is included, such as skin, cutaneous<br>tissue, subcutaneous tissue, striated and<br>smooth tissue, muscle, cartilage<br>meniscus, mucous membrane, lymph<br>vessels and nodes, organs and glands.<br>Suggested applications include:<br><br>General Surgery: Vaporizing,<br>coagulating, incising, excising, debulking,<br>and ablating of soft tissue as well as in<br>endoscopic (e.g., laparoscopic) or open<br>surgeries.<br><br>Gastroenterology: Tissue ablation and<br>hemostasis in the gastrointestinal tract;<br>esophageal neoplastic obstructions,<br>including squamous cell carcinoma and<br>adenocarcinoma; gastrointestinal<br>hemostasis (including varices,<br>espohagitis, esophageal ulcer, Mallory-<br>Weiss tear, gastric ulcer, angiodysplasia,<br>stomal ulcers non-bleeding ulcers | The GreenLight XPS Laser System is<br>intended for the surgical incision/excision,<br>vaporization, ablation, hemostasis and<br>coagulation of soft tissue. All soft tissue is<br>included, such as skin, cutaneous tissue,<br>subcutaneous tissue, striated and smooth<br>tissue, muscle, cartilage meniscus, mucous<br>membrane, lymph vessels and nodes,<br>organs and glands. Suggested applications<br>include:<br><br>General Surgery: Vaporizing, coagulating,<br>incising, excising, debulking, and<br>ablating of soft tissue as well as in<br>endoscopic (e.g., laparoscopic) or open<br>surgeries.<br><br>Gastroenterology: Tissue ablation and<br>hemostasis in the gastrointestinal tract;<br>esophageal neoplastic obstructions,<br>including squamous cell carcinoma and<br>adenocarcinoma; gastrointestinal<br>hemostasis (including varices, espohagitis,<br>esophageal ulcer, Mallory-Weiss tear,<br>gastric ulcer, angiodysplasia, stomal ulcers, | Same |
| Specification | Subject Device | Predicate Device – Greenlight XPS Laser | Comparison |
| | K240159 | System (K092735) | |
| | gastric erosions); gastrointestinal tissue<br>ablation (benign and | non-bleeding ulcers, gastric erosions);<br>gastrointestinal tissue ablation (benign and | |
| | malignant neoplasm, angiodysplasia, | malignant neoplasm, angiodysplasia, | |
| | polyps, ulcer, colitis, hemorrhoids). | polyps, ulcer, colitis, hemorrhoids). | |
| | Gynecology: Vaporizing, incising, or<br>coagulating tissue associated with<br>treatments of conditions such as:<br>endometriosis; cervical, vulvar, and<br>vaginal intraepithelial neoplasia;<br>condyloma acuminata; uterine septum;<br>intrauterine adhesions; submucosal<br>fibroids. | Gynecology: Vaporizing, incising, or<br>coagulating tissue associated with<br>treatments of conditions such as:<br>endometriosis; cervical, vulvar, and vaginal<br>ntraepithelial<br>neoplasia; condyloma acuminata; uterine<br>septum; intrauterine adhesions;<br>submucosal fibroids. | |
| | Head and Neck/ Otorhinolaryngology<br>(ENT): Tissue incision, excision, ablation,<br>and vessel hemostasis.<br>Neurosurgery: Incising, excising,<br>coagulating, and vaporizing neurological | Head and Neck/ Otorhinolaryngology<br>(ENT): Tissue incision, excision, ablation,<br>and vessel hemostasis.<br>Neurosurgery: Incising, excising,<br>coagulating, and vaporizing neurological | |
| | tumors of the firm textured type. | tumors<br>of the firm textured type. | |
| | Ophthalmology: | | |
| | Post-vitrectomy endophotocoagulation | Ophthalmology: | |
| | of the retina. | Post-vitrectomy endophotocoagulation of<br>the retina. | |
| Specification | Subject Device<br>K240159 | Predicate Device - Greenlight XPS Laser<br>System (K092735) | Comparison |
| | Plastic Surgery: Vaporizing, coagulating,<br>incising, excising, debulking, and ablating<br>of soft tissue in endoscopic and open<br>procedures. | Plastic Surgery: Vaporizing, coagulating,<br>incising, excising, debulking, and ablating<br>of soft tissue in endoscopic and open<br>procedures. | |
| | Spinal Surgery: Percutaneous lumbar<br>diskectomy. | Spinal Surgery: Percutaneous lumbar<br>diskectomy. | |
| | Thoracic Surgery: Vaporizing,<br>coagulating, incising, excising, debulking,<br>and ablating of soft tissue, including lung<br>tissue in thoroscopic or open<br>procedures. | Thoracic Surgery: Vaporizing, coagulating,<br>incising, excising, debulking, and ablating of<br>soft tissue, including lung tissue in<br>thoroscopic or open procedures. | |
| | Urology: Cutting, coagulating, or<br>vaporizing urologic soft tissues. Open<br>endoscopic minimally invasive urological<br>surgery (ablation, vaporization, incision,<br>excision and coagulation of soft tissue)<br>including treatment of: bladder, urethral<br>& ureteral tumors; condylomas; lesions<br>of external genitalia; urethral & penile;<br>hemangioma; urethral strictures;<br>bladder neck obstructions; and<br>vaporization of prostate tissue for men<br>suffering from benign prostate<br>hyperplasia/ hypoplasia (BPH). | Urology: Cutting, coagulating, or vaporizing<br>urologic soft tissues. Open endoscopic<br>minimally invasive urological surgery<br>(ablation, vaporization, incision, excision<br>and<br>coagulation of soft tissue) including<br>treatment of: bladder, urethral & ureteral<br>tumors;<br>condylomas; lesions of external genitalia;<br>urethral & penile; hemangioma; urethral<br>strictures; bladder neck obstructions; and<br>vaporization of prostate tissue for men<br>suffering from benign prostate<br>hyperplasia/hypoplasia (BPH) | |
| Specification | Subject Device<br>K240159 | Predicate Device – Greenlight XPS Laser<br>System (K092735) | Comparison |
| Laser Type | Diode Laser | KTP Laser | Different. |
| Laser Power | Up to 30 W | Up to 180W | Different.<br>See<br>discussion<br>below. |
| Wavelength | 455nm +/-10nm | 532nm | Different.<br>Absorption<br>spectra are<br>very close for<br>532nm and<br>455nm, and<br>performance<br>testing shows<br>comparable<br>performance<br>for the<br>desired<br>indications. |
| Laser Class | 4 | 4 | Same |
| Operation Mode | Continuous Wave, pulsed wave, Quasi-pulsed wave, Quasi-continuous wave | Unknown | Different.<br>Performance<br>testing was<br>conducted<br>with CW and<br>QC-W for the<br>VYLO to<br>represent<br>worst case. |
| Specification | Subject Device<br>K240159 | Predicate Device – Greenlight XPS Laser<br>System (K092735) | Comparison |
| Pulse<br>Length/Duration | 1ms to 200ms (operation mode dependent) and continuous wave | Unknown | See testing<br>discussion<br>below. |
| Repetition Rate | Up to 1000 pulses per second (quasi-continuous mode) | Unknown | Different. See<br>discussion<br>below. |
| Fluence | 300μm: 5,163 – 51,629 J/cm2<br>400μm: 2,867 – 28,671 J/cm2<br>600μm: 1,263 – 12,627 J/cm2 | Unknown | Different. See<br>testing<br>discussion<br>below. |
| Aiming Beam<br>Wavelength | 515nm | Unknown | Different.<br>Though<br>slightly<br>different in<br>wavelength,<br>both produce<br>similar visible<br>light for the<br>aiming beam |
| Aiming Beam Power | 5mW…