Manufacturer
InnovoyceInnoVoyce VYLO
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K240159
- Device name
- InnoVoyce VYLO
- Company
- Innovoyce
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-01-19
- Decision date
- 2024-05-29
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
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, esophagitis, esophageal 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, excision, 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, 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, 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 (BPH).
Intended 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, 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, excision, 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, 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, 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).
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.
Summary parsed at:2026-06-01 05:27:23 UTC
Predicate devices
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Cited as predicate
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