(74 days)
Not Found
No
The 510(k) summary describes a surgical laser system and its intended uses for various soft tissue procedures. There is no mention of any AI or ML components in the device description, intended use, or performance studies. The device appears to be a traditional laser system controlled by a touch-screen PC.
No
This device is a surgical laser system used for incision, excision, vaporization, ablation, and coagulation of soft tissue, which are procedures rather than therapeutic outcomes.
No
The device is described as a surgical laser instrument intended for various surgical procedures such as incision, excision, vaporization, ablation, coagulation, and hemostasis of soft tissue, which are therapeutic actions rather than diagnostic ones.
No
The device description clearly outlines hardware components such as a rack, cooling units, laser source, power supply, laser head, optical bench, power meter, SMA connector, optical fiber, emergency push button, key-switch, status led, footswitch connector, metal door, magneto-thermal switch, line cable, safety interlock connector, and a touch-screen PC. These are physical components, not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this laser system is used for surgical procedures directly on soft tissue within the human body (incision, excision, vaporization, ablation, coagulation, hemostasis).
- The device description focuses on the laser technology and its application in surgery. There is no mention of analyzing biological samples or providing diagnostic information based on those samples.
The device is a surgical laser system intended for therapeutic and procedural use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
532nm Applications:
The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation 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.
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 intraepitheal 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.
Opthamology:
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:
Outting, 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, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
2.01 um Applications:
The Cyber Surgical Laser Family and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery, and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
- Tumors.
- Ablation of Benign Prostatic Hypertrophy (BHP),
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation vaporization, coagulation and hemostasis) including: - Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitas
- Hemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) - Intra-uterine treatment of submucous fibroids, benign endometrial polyps.
- and uterine septum by incision, excision, ablation and or vessel
- coagulation
- Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: - Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
General Surnqery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: - Cholecystectomy
- Lysis of adhesion
- Appendectomy
- Biopsy
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial Nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of Decubitus Ulcer
- Hemorrhoids
- Debridement of Statis Ulcer
- Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) - Ablation of soft and cartilaginous tissue in Minimal Invasive -Spinal
- Surgery including
- Percutaneous Laser Disc Decompression/Discectomy
- Foraminoplasty
- Ablation and coagulation of soft vascular and non vascular tissue in
- minimally invasive spinal surgery.
Product codes
GEX
Device Description
The Cyber Surgical Laser Family is a surgical laser instrument for use in general surgery and dermatology. The Cyber Surgical Laser Family includes 3 models:
-
Cyber Green (532nm, 120W)
-
Cyber Tm (2.01μm, 120W)
-
Cyber Green/Tm (532nm and 2.01μm, 120W@532nm; 120W@2.01μm)
-
Model Cyber Green is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery and Urology.
-
Model Cyber Tm is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Gynecology, ENT, General Surgery and Arthroscopy
-
Model Cyber Green/Tm is a combination of Cyber Green and Cyber Tm. The indication for use is the same of Cyber Green and Cyber Tm.
The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed.
The Cyber Green includes a Q-Switch Nd: YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W.
The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01um wavelength with power adjustable from 5 to 120W.
The Cyber Green/Tm includes a Q-Switch Nd:YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W, and a Tm:YAG Laser Source that emit a Cw laser light at 2.0lum wavelength with power adjustable from 5 to 120W.
An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600um) and bare fibers (200, 400 and 600um) are available for both laser source.
The emergency red push button, the key-switch and the operation status led are housed in the front part of the system.
The footswitch connector is housed in the back side of the system. A metal door closes the lower rack.
On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chillers outlet grids cooling.
The device is controlled by a touch-screen PC mounted on a oriental arm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All 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, Head and Neck, Otorhinolaryngology (ENT), neurological tumors, retina, lumbar, lung tissue, urologic soft tissues, Bladder, Urethral, Ureteral, external genitalia, penile, prostate, gall bladder, biliary/bile duct, pancreas, colon, rectum, anus, uterus, cervix, sinuses, oral, nasal, glossal, pharyngeal, laryngeal, tonsils, adenoids, internal organs, breast, liver, spleen, thyroid, parathyroid, hernia, lymph nodes, kidney, pilonidal, lipoma, decubitus ulcer, statis ulcer, spinal.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY Quanta System Cyber Surgical Laser Family
Title:
JUN 19 2009
Submitter:
Quanta System SpA via IV Novembre,116
21058 Solbiate Olona VA / Italy
Contact:
Dr. Isabella Carrer Medical Division Manager
| Date Prepared: | June 11, 2008 |
|---|---|
| Device Trade Name: | Quanta System Cyber Surgical Laser Family |
| Common Name: | Laser surgical instrument for use in general surgery and |
| dermatology | |
| Classification Name: | Instrument, surgical, powered, laser |
| Predicate Devices: | - AllMed System Revolix 120 Laser System |
| (K070476); |
- Laserscope GreenLight HPS Series Surgical
Laser and System Accessories (K062719); |
| Intended Use /
Indications for Use: | 532nm Applications:
The Cyber Surgical Laser Family and Accessories are
intended for the surgical incision/excision, vaporization,
ablation 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. |
| | 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 |
1
squamous cell carcinoma and adenocarcinoma: Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Nonbleeding 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 intraepitheal 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.
Opthamology:
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, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
2
2.01um Applications:
The Cyber Surgical Laser Family and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery, and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures -
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
- Tumors.
- Ablation of Benign Prostatic Hypertrophy (BHP),
- Transurethral incision of the .. prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas -
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Appendectomy "
- Polyps
- Biopsy
- Gall Bladder calculi
3
-
Gall Bladder calculi -
-
Biliary/Bile duct calculi
-
Ulcers .
-
Gastric ulcers ﮯ
-
Duodenal ulcers ㅠ
-
Non Bleeding Ulcers -
-
Pancreatitas -
-
Hemorrhoids -
-
Cholecystectomy -
-
Benign and Malignant Neoplasm -
-
Angiodysplasia -
-
Colorectal cancer -
-
Telangiectasias
-
Telangiectasias of the Osler-Weberu Renu disease
-
Vascular Malformation -
-
Gastritis
-
Esophagitis
-
Esophageal ulcers
-
Varices
-
Colitis
-
Mallory-Weiss tear
-
Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection,
ablation, vaporization, coagulation and hemostasis)
- Intra-uterine treatment of submucous fibroids, benign endometrial polyps,
- and uterine septum by incision, । excision, ablation and or vessel
- coagulation -
- Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation,
vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
4
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
- Functional endoscopic sinus surgery .
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystectomy -
- Lysis of adhesion -
- Appendectomy -
- Biopsy *
- Skin incision u
- Tissue dissection -
- Excision of external tumors and lesions
- Complete or partial resection of * internal organs, tumors and lesions
- Mastectomy ﮯ
- Hepatectomy -
- Pancreatectomy ~
- Splenectomy -
- Thyroidectomy -
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy ﺴ
- Lymphadenectomy
- Partial Nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of Decubitus Ulcer
- Hemorrhoids
- Debridement of Statis Ulcer
- Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
5
- Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal
- Surgery including -
- = Percutaneous Laser Disc Decompression/Discectomy
- Foraminoplasty -
- Ablation and coagulation of soft . vascular and non vascular tissue in
- minimally invasive spinal surgery.
The Cyber Surgical Laser Family is a surgical laser instrument for use in general surgery and dermatology. The Cyber Surgical Laser Family includes 3 models:
| Models | Wavelength | Laser Power |
|---|---|---|
| Cyber Green | 532nm | 120W |
| Cyber Tm | 2.01μm | 120W |
| Cyber Green/Tm | 532nm and | |
| 2.01μm | 120W@532nm; | |
| 120W@2.01μm |
- Model Cyber Green is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery and Urology.
- Model Cyber Tm is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Gynecology, ENT, General Surgery and Arthroscopy
- Model Cyber Green/Tm is a combination of Cyber Green and Cyber Tm. The indication for use is the same of Cyber Green and Cyber Tm.
The device consists of a rack that houses the cooling units (2 chillers), the laser source and the power
Technological Characteristics:
6
supply. Above the rack, into a cover-proof light, the laser head and optical bench with the beam delivery optics and the power meter are housed.
The Cyber Green includes a Q-Switch Nd: YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W.
The Cyber Tm includes a Tm:YAG Laser Source that emit a Cw laser light at 2.01um wavelength with power adjustable from 5 to 120W.
The Cyber Green/Tm includes a Q-Switch Nd:YAG frequency doubled Laser Source (KTP) that emit a pulsed laser light at 532nm with power adjustable from 0.5 to 120W, and a Tm:YAG Laser Source that emit a Cw laser light at 2.0lum wavelength with power adjustable from 5 to 120W.
An SMA connector allows the connection of an optical fiber in which the main beam and the 650nm aiming beam are launched. Sidefire fibers (600um) and bare fibers (200, 400 and 600um) are available for both laser source.
The emergency red push button , the key-switch and the operation status led are housed in the front part of the system.
The footswitch connector is housed in the back side of the system. A metal door closes the lower rack.
On the back panel are housed the magneto-thermal switch (circuit braker), the line cable with IEC309 /32A plug and a safety interlock connector. The rear panel also contains the power supply and chillers outlet grids cooling .
The device is controlled by a touch-screen PC mounted on a oriental arm.
Performance Data
None
Substantial Equivalence: The Quanta System Cyber Surgical Laser Family is as safe and effective as the predicate devices. The Cyber Surgical Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Cyber Surgical Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Cyber Surgical Laser Family is substantially equivalent.
7
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
JUN 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job Reviewer 1394 25th Street NW Buffalo, Minnesota 55313
Re: K090962
Trade/Device Name: Cyber Surgical Laser Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and In Dermatology Regulatory Class: II Product Code: GEX Dated: June 8, 2009 Received: June 10, 2009
Dear Mr. Job:
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 (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. 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.
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.
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.
8
Page 2-Mr. Mark Job
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdith/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use Statement
510(k) Number (if known): K090962
Device Name: Cyber Surgical Laser Family
Indications for Use:
532nm Applications:
The Cyber Surgical Laser Family and Accessories are intended for the surgical incision/excision, vaporization, ablation 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.
General Surgery:
Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. Iaparoscopic) 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 intraepitheal 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.
Opthamology:
Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery:
NikhRojdin for
and ablating of soft tissue in
Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Spinal Surgery:
510(k) Number K090962
10
Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, Coagulating. Incising, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology:
Outting, 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, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
2.01 um Applications:
The Cyber Surgical Laser Family and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery, and Arthroscopy
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral
- Tumors.
- Ablation of Benign Prostatic Hypertrophy (BHP),
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostrate (HoLRP)
- Laser Enuculeation of the Prostate (HoLEP)
- Laser Ablation of the Prostate (HoLAP)
- Condylomas
- Lesions of external genitalia
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation vaporization, coagulation and hemostasis) including:
- Appendectomy
- Polyps
- Biopsy
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090962
11
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- Gastric ulcers
- Duodenal ulcers
- Non Bleeding Ulcers
- Pancreatitas
- Hemorrhoids
- Cholecystectomy
- Benign and Malignant Neoplasm
- Angiodysplasia
- Colorectal cancer
- Telangiectasias
- Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices
- Colitis
- Mallory-Weiss tear
- Gastric Erosions
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
- Intra-uterine treatment of submucous fibroids, benign endometrial polyps.
- and uterine septum by incision, excision, ablation and or vessel
- coagulation
- Soft tissue excision procedures such as excisional conization of the cervix
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery
- Partial turbinectomy
- Polypectomy
- Dacryocystorhinostomy
- Frontal Sinusotomy
- Ethmoidectomy
- Maxillary antrostomy
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Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090962
12
- Functional endoscopic sinus surgery
- Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal
- Tonsillectomy
- Adenoidectomy
General Surnqery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Cholecystectomy
- Lysis of adhesion
- Appendectomy
- Biopsy
- Skin incision
- Tissue dissection
- Excision of external tumors and lesions
- Complete or partial resection of internal organs, tumors and lesions
- Mastectomy
- Hepatectomy
- Pancreatectomy
- Splenectomy
- Thyroidectomy
- Parathyroidectomy
- Herniorrhaphy
- Tonsillectomy
- Lymphadenectomy
- Partial Nephrectomy
- Pilonidal Cystectomy
- Resection of lipoma
- Debridement of Decubitus Ulcer
- Hemorrhoids
- Debridement of Statis Ulcer
- Biopsy
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)
- Ablation of soft and cartilaginous tissue in Minimal Invasive -Spinal
- Surgery including
- Percutaneous Laser Disc Decompression/Discectomy
- Foraminoplasty
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090962
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
13
- Ablation and coagulation of soft vascular and non vascular tissue in
- minimally invasive spinal surgery.
Prescription Use _ X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090962