(131 days)
Not Found
No
The summary describes a laser device for surgical procedures with different emission modes. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The performance studies focus on the physical effects of the laser on tissue.
Yes
The device is described as being used for surgical incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, which are all therapeutic procedures. The intended uses listed cover a wide range of medical conditions and surgical interventions.
No
The device is intended for surgical incision/excision, vaporization, ablation, hemostasis, and coagulation of soft tissue, which are all therapeutic procedures, not diagnostic ones.
No
The device description explicitly states that the InnoVoyce VYLO is a "solid-state laser device with laser energy generated by internal diodes" and includes a "base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs." This indicates it is a hardware device that utilizes software for control and interface, not a software-only medical device.
Based on the provided information, the InnoVoyce VYLO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device's function as a surgical tool for directly interacting with and modifying soft tissue within the body (incision, excision, vaporization, ablation, hemostasis, coagulation). This is an in vivo application.
- Device Description: The description details a laser device that delivers energy to tissue. This aligns with a surgical instrument, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue samples, etc.) or to provide diagnostic information based on such analysis. The device's function is therapeutic and surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The InnoVoyce VYLO's purpose is to perform surgical procedures directly on the patient's body.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands, gastrointestinal tract, esophageal, cervical, vulvar, vaginal, uterine, intracranial, retina, lumbar, lung tissue, urologic soft tissues, bladder, urethral, ureteral, external genitalia, penile, prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional practitioners (specialized physician/ authorized technical personnel) in the medical field; professional healthcare facility environments.
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
For the VYLO device, 300 and 600 microns LOFs were tested at 30 W in CW mode ~ 2 mm distance and 3 mm/sec translation speed to mimic the worst case. For the 600 microns LOFs, testing at 20 W at CW and Q-CW was also performed. All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle) as recommended by FDA guidance for Industry for Premarket Notification.
The predicate device was assessed side-by-side to the VYLO at Q-CW emission mode at two power levels 30 and 180 W. 30 W mimics the max power level of the VYLO device, and 180 W is maximum power level the Predicate is cleared for. The Predicate was also tested on all three types of test tissues and each setting was triplicated. All other treatment parameters were also identical (at 37C, 2 mm distance from the surface, and 3 mm/sec translation speed).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to verify the pulse width, power output, and repetition rate. Histology testing was conducted side by side with the predicate device to demonstrate in a worst case scenario. Testing was conducted using the cleared laser fiber.
For the VYLO device, 300 and 600 microns LOFs were tested at 30 W in CW mode ~ 2 mm distance and 3 mm/sec translation speed to mimic the worst case. For the 600 microns LOFs, testing at 20 W at CW and Q-CW was also performed. All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle).
The predicate device was assessed side-by-side to the VYLO at Q-CW emission mode at two power levels 30 and 180 W. 30 W mimics the max power level of the VYLO device, and 180 W is maximum power level the Predicate is cleared for. The Predicate was also tested on all three types of test tissues and each setting was triplicated. All other treatment parameters were also identical (at 37C, 2 mm distance from the surface, and 3 mm/sec translation speed).
The study demonstrated that the treatments produced clearly detectable Coagulation and Ablation Zones (CAZs) in all three treated tissues at all dose levels for both devices. Dimensions of the CAZs were not significantly different when 300- and 600- microns tips were used. Increasing the power level from 20- to 30 W did not significantly influence the thermally damage profiles produced by the VYLO Device. Relatively shallower CAZ's were observed for the VYLO Device when treatment was performed on Q-CW vs CW at the same power level. The dimensions of the CAZs produced by the Predicate Device at 30 W were in close proximity to the CAZs produced by the VYLO Device at 30 W. However, the dimensions of the CAZs produced by the Predicate Device at its maximum power level (180 W) were larger (deeper and wider) than damage produced by the VYLO Device at its maximum power level. These data are consistent across all three types of test tissue specimens.
The obtained data allows one to conclude the VYLO's thermal damage profiles were consistent across all three test specimens for all tested parameters. The study also demonstrated the ability of the VYLO to deliver consistent thermal damage profiles comparable to the profiles produced by the Predicate Device at the similar power level. The dimensions of CAZs of the VYLO Device at the worst cases (max power level) are relatively smaller than the dimensions of the Predicate Device. Thus, it can be concluded that treatment by the VYLO device at the maximum dose settings will provide a similar clinical effect to the Predicate Device in a safer and more controlled way, because the lesions profiles at worst cases (at max power levels 30 W at CW vs. 180 W at Q-CW) for the VYLO Device is smaller compared to Predicate device. It can be concluded that treatment by such a device at the appropriate testing settings will possess a desirable clinical treatment effect.
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.
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 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
1
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).
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@fda.hhs.gov) or phone (1-800-638-2041 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
3
Indications for Use
Submission Number (if known)
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).
4
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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5
| Applicant | InnoVoyce, LLC |
|---|---|
| Address | One Beacon Street, Floor 15 |
| Boston, MA 02108 | |
| Sponsor Contact | Stephen Mais |
| Stephen.mais@innovoyce.com | |
| Regulatory Contact | Aubrey Thompson, Regulatory Consultant |
| Aubreythompson@hoyregulatory.com | |
| 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 |
| 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;
6
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).
7
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 | ||
| surgical incision/excision, | |||
| 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, excising, 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 | The GreenLight XPS Laser System is
intended for the surgical incision/excision,
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, excising, 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, | Same |
| Specification | Subject Device | Predicate Device – Greenlight XPS Laser | Comparison |
| | K240159 | System (K092735) | |
| | gastric erosions); gastrointestinal tissue
ablation (benign and | non-bleeding ulcers, gastric erosions);
gastrointestinal tissue ablation (benign and | |
| | malignant neoplasm, angiodysplasia, | malignant neoplasm, angiodysplasia, | |
| | polyps, ulcer, colitis, hemorrhoids). | 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. | Gynecology: Vaporizing, incising, or
coagulating tissue associated with
treatments of conditions such as:
endometriosis; cervical, vulvar, and vaginal
ntraepithelial
neoplasia; condyloma acuminata; uterine
septum; intrauterine adhesions;
submucosal fibroids. | |
| | Head and Neck/ Otorhinolaryngology
(ENT): Tissue incision, excision, ablation,
and vessel hemostasis.
Neurosurgery: Incising, excising,
coagulating, and vaporizing neurological | Head and Neck/ Otorhinolaryngology
(ENT): Tissue incision, excision, ablation,
and vessel hemostasis.
Neurosurgery: Incising, excising,
coagulating, and vaporizing neurological | |
| | tumors of the firm textured type. | tumors
of the firm textured type. | |
| | Ophthalmology: | | |
| | Post-vitrectomy endophotocoagulation | Ophthalmology: | |
| | of the retina. | Post-vitrectomy endophotocoagulation of
the retina. | |
| Specification | Subject Device
K240159 | Predicate Device - Greenlight XPS Laser
System (K092735) | Comparison |
| | Plastic Surgery: Vaporizing, coagulating,
incising, excising, debulking, and ablating
of soft tissue in endoscopic and open
procedures. | Plastic Surgery: Vaporizing, coagulating,
incising, excising, debulking, and ablating
of soft tissue in endoscopic and open
procedures. | |
| | Spinal Surgery: Percutaneous lumbar
diskectomy. | 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. | 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,
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/ hypoplasia (BPH). | Urology: Cutting, coagulating, or vaporizing
urologic soft tissues. Open endoscopic
minimally invasive urological surgery
(ablation, vaporization, incision, 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/hypoplasia (BPH) | |
| Specification | Subject Device
K240159 | Predicate Device – Greenlight XPS Laser
System (K092735) | Comparison |
| Laser Type | Diode Laser | KTP Laser | Different. |
| Laser Power | Up to 30 W | Up to 180W | Different.
See
discussion
below. |
| Wavelength | 455nm +/-10nm | 532nm | Different.
Absorption
spectra are
very close for
532nm and
455nm, and
performance
testing shows
comparable
performance
for the
desired
indications. |
| Laser Class | 4 | 4 | Same |
| Operation Mode | Continuous Wave, pulsed wave, Quasi-pulsed wave, Quasi-continuous wave | Unknown | Different.
Performance
testing was
conducted
with CW and
QC-W for the
VYLO to
represent
worst case. |
| Specification | Subject Device
K240159 | Predicate Device – Greenlight XPS Laser
System (K092735) | Comparison |
| Pulse
Length/Duration | 1ms to 200ms (operation mode dependent) and continuous wave | Unknown | See testing
discussion
below. |
| Repetition Rate | Up to 1000 pulses per second (quasi-continuous mode) | Unknown | Different. See
discussion
below. |
| Fluence | 300μm: 5,163 – 51,629 J/cm2
400μm: 2,867 – 28,671 J/cm2
600μm: 1,263 – 12,627 J/cm2 | Unknown | Different. See
testing
discussion
below. |
| Aiming Beam
Wavelength | 515nm | Unknown | Different.
Though
slightly
different in
wavelength,
both produce
similar visible
light for the
aiming beam |
| Aiming Beam Power | 5mW | 5mW | same |
| Optical Fiber Core
Diameter | 300µm fiber: 272µm core diameter
400µm fiber: 365µm core diameter
600µm fiber: 550µm core diameter | Unknown | Different.
See
discussion
below. |
| Cooling | Internal coolant | Unknown | Different |
| Specification | Subject Device
K240159 | Predicate Device – Greenlight XPS Laser
System (K092735) | Comparison |
| Display | Touchscreen | Touchscreen | Same |
| Main Power Supply | 100VAC to 240VAC +/- 10%
50Hz to 60Hz