(68 days)
Not Found
Not Found
No
The description focuses on the physical components and technical specifications of a surgical laser system, with no mention of AI or ML capabilities.
Yes
The device is a surgical laser system intended for various medical applications, which fall under the definition of therapeutic use.
No
The device is described as a "Surgical Laser System" intended for "applications in the following specialities: Dermatology, Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery and Urology." It uses laser light for surgical procedures, not for diagnosis.
No
The device description explicitly details hardware components such as a laser source (Nd:YAG), crystals (KTP), a q-switch, a power supply, a heat exchanger, and lamp reflectors. This indicates it is a physical medical device with hardware, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description: The description clearly states that this is a "Surgical Laser System" used for various surgical applications. It describes how the laser light is generated and delivered.
- Intended Use/Indications for Use: The intended uses are all surgical procedures performed directly on the patient's body in various medical specialties. There is no mention of analyzing specimens outside the body.
Therefore, the Laserscope 800 Series Surgical Laser System is a therapeutic surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is intended to be used for all currently cleared Laserscope indications. These indications include applications in the following specialities:
KTP/532 nm Applications: Dermatology. Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery and Urology.
The 800 Series Surgical Laser System and Accessories is intended to be used for the following indications:
KTP/532 nm Applications:
Dermatology - Indications include photocoagulation, hemostasis, color lightening, blanching flattening and reduction of lesion size for the following categories of lesions: vascular lesions including angiomas, hemangiomas, telangiectasia; benign pigmented lesions including nevi, lentigines, chloasma, cafe-au-lait, tattoos; culaneous lesions including verrucae, skin tags, keratoses and plaques.
Gasteroenterology - indications for hemostasis in the gastrointestinal tract including varices, esophagitis, esophageal uicer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erostons. Indications for tissue ablation in the gastrointestinal tract including benign and malignant neoplasms, angiodysplassia, polyps, uicers, collitis and hemormoids. Indications for esophageal neoplastic obstructions including squarnous cell carcinoma and adenocarcinoma.
General Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue in endoscopic or open procedures.
Gynecology - indications include vaporization, incision and coagulation of tissue associated with treatments for conditions such as endometriosis; carvical, vulvar and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions and submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, excision ablation and vessel hemostasis.
Neurosurgery - indications include incision, excision, coagulation and vaportzation, of neurosurgical turnors of the firm, textured type.
Ophthalmology - indications include post-vitrectorny endophotocoagulation of the retina.
Plastic Surgery - indications include vaporization, coagulation, incision, excision, debutking and ablation of soft tissue in endoscopic and open procedures.
Spinal Surgery - indications include percutaneous lumbar discectorny.
Thoracic Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue, including lung tissue in thoracoscopic or open procedures.
Urology - indications include cutting, coagulation or vaporization of soft tissue dunk urologic procedures.
Nd:YAG/1064 Applications:
Dermatology - indications include photocoagulation of pigmented vascular lesions to reduce lesion size: for patients with lesions that would potentially benefit from aggressive treatment; and for patients with lesions that have not responded to other laser treatments.
Gasteroenterology - indications for hemostasis in the gastrointestinal tract, including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric uicer, anoiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erosions. Indications for tissue ablation in the gastrointestinal tract including benign and mallgnant neoplasms, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Indications for esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma.
General Surgery - indications include cutting, ablation and/or hemostasis of soft tissue in endoscopic/laparoscopic and open general surgical applications, including cholecystectorny. appendectorny, vagotomy and pyloromyotomy. Soft tissue general surgical indications include skin incision, tissue dissection, excision of external turnors and lessions, tissue ablation, vessel coaculation and complete or partial resection of internal organs, turnors and lesions.
Genecology - indications include treatment of menormagia by photocoagulation of the endometrial lining of the uterus; ablation of endometrial implants and/or peritoneal adhesions: soft tissue excisional procedures, such as excision of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated, including submucous fibroids, benign endometrial polyps and uterine septum.
Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, exclision, ablation and vessel hemostasis.
Hemostasis During Surgery - indications include adjunctive coaculation and hemostasis (bleeding control) during surgery in endoscopic and epen procedures.
Neurosurgery - indications include hemostasis for pituitary turnor. meningloma. hemoglioblastoma. AVMs. diloblastoma. astrocytoma and oligodendroglioma.
Oculoplastics - indications include incision, excision and/or coagulation of tissue in oculoplastic procedures such as operations on the lacrimal system, operations on the evelids, removal or biopsy of orbital turnors, enucleation of eyeball, exemeration of orbital contents.
Orthopedics - indications include cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
Plastic Surgery - indications include cutting, incision, coagulation and vaporization of soft tissue.
Pulmonary Surgery - indications include palliative procedures for benign and mallignant pulmonary airway obstructions, including squarnous cell carcinoma, carcinoma, carcinoid. benign turnors, granulomas, tracheal stenosis and benion strictures.
Thoracic Surgery - indications incision, excision, excision, coagulation and vaportzation of soft tissue. Thoracic applications, including isolation of vessels for endarterectorny and/or bypass grafts, wedge resections, thoracotomy, formation of pacemaker pockets, vaporization, coagulation, incision, excision debulking and aprilion of lung tissue (thoracoscopy).
Urology - Indications include superficial urinary bladder turnors, invasive bladder carcinoma. urethreal strictures, bladder neck contracture, diverticulum and lesions of the external genitalia (including condyloma acuminata).
Product codes
GEX
Device Description
The Laserscope 800 Series Surgical Laser System is currently available in 8 configurations, 7 which have a KTP laser emitting light at 532 nm. This is achieved by passing the infrared beam produced by the Nd: Y A G source through a second crystal made from potassium titanyl phosphate (KTP). The process that converts the infrared light to the visible green light requires two photons of infrared light to produce one photon of ereen light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: Y AG beam.
The Laserscope 800 Series Surgical Laser Sytem (KTP Upgrade) is achieved by an upgraded, higher quality q-switch and driver; increasing the power supply; adding a water to water heat exchanger and utilizing silicone based titanium dioxide lamp reflectors. Four new configurations are available:
Model 833, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Dual Port
Model 834, 2XP: 50 watts KTP/532, 100 watts Nd:YAG/1064, Single Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd: YAG/1064, Dual Port
Model 843, 3XP: 60 watts KTP/532, 100 watts Nd:YAG/1064, Single Port
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermatology, Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery, Urology
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
970948
000011
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE 800 SERIES SURGICAL LASER SYSTEM (KTP UPGRADE) AND ACCESSORIES
REGULATORY AUTHORITY
Safe Medical Device Act of 1990, 21 CFR 807.92
MAY 2 | 1997
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134 Phone: 408 943-0636 FAX: 408-943-1454
DEVICE TRADE NAME:
800 Series Surgical Laser System and Accessories
DEVICE COMMON NAME:
Laser Instrument, Surgical, Powered
DEVICE DESCRIPTION:
The Laserscope 800 Series Surgical Laser System is currently available in 8 configurations, 7 which have a KTP laser emitting light at 532 nm. This is achieved by passing the infrared beam produced by the Nd: Y A G source through a second crystal made from potassium titanyl phosphate (KTP). The process that converts the infrared light to the visible green light requires two photons of infrared light to produce one photon of ereen light. This conversion process halves the wavelength, or doubles the frequency, so the wavelength of the KTP beam is exactly half that of the Nd: Y AG beam.
The Laserscope 800 Series Surgical Laser Sytem (KTP Upgrade) is achieved by an upgraded, higher quality q-switch and driver; increasing the power supply; adding a water to water heat exchanger and utilizing silicone based titanium dioxide lamp reflectors. Four new configurations are available:
| Model 833, 2XP: | 50 watts KTP/532, 100 watts Nd:YAG/1064, Dual Port |
|---|---|
| Model 834, 2XP: | 50 watts KTP/532, 100 watts Nd:YAG/1064, Single Port |
| Model 843, 3XP: | 60 watts KTP/532, 100 watts Nd: YAG/1064, Dual Port |
| Model 843, 3XP: | 60 watts KTP/532, 100 watts Nd:YAG/1064, Single Port |
Laserscope Premarket Notification For 800 Series Surgical Laser Systems
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
The 800 Series Surgical Laser System (KTP Upgrade) and Accessories has been classified as a Class II medical device by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
The 800 Series Surgical Laser System (KTP Upgrade) and Accessories conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATIONS FOR USE STATEMENT:
The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is intended to be used for all currently cleared Laserscope indications. These indications include applications in the following specialities:
KTP/532 nm Applications: Dermatology. Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Ophthalmology, Spinal Surgery, Plastic Surgery, Thoracic Surgery and Urology.
COMPARISON WITH PREDICATE DEVICE:
The 800 Series Surgical Laser System (KTP Upgrade) and Accessories is substantially equivalent to the Laserscope 800 Series Surgical Laser System and Accessories.
The risks and benefits for the 800 Series Surgical Laser System (KTP Upgrade) and Accessories are comparable to the predicate device when used for similar clinical applications.
Since the 800 Series Surgical Laser System (KTP Upgrade) and Accessories is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
Laserscope Premarket Notification For 800 Series Surgical Laser Systems
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized eagle-like symbol with three wavy lines beneath it, representing water or waves. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1997
Ms. Lisa McGrath Senior Regulatory Affairs Specialist Laserscope 3052 Orchard Drive San Jose, California 95134-2011
K970948 Re: Trade Name: 800 Series Surgical Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: March 13, 1997 Received: March 14, 1997
Dear Ms. McGrath:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA mav publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Lisa McGrath
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. - - --------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Q ot
| 510(K) Number: | 970948 |
|---|---|
| Device Name: | 800 Series Surgical Laser System (KTP/532, KTP/532 and |
| Nd:YAG/1064 and Nd:YAG/1064 Configurations) and | |
| Accessories | |
| Indications for Use: | The 800 Series Surgical Laser System and Accessories is |
| intended to be used for the following indications: |
KTP/532 nm Applications:
Dermatology - Indications include photocoagulation, hemostasis, color lightening, blanching flattening and reduction of lesion size for the following categories of lesions: vascular lesions including angiomas, hemangiomas, telangiectasia; benign pigmented lesions including nevi, lentigines, chloasma, cafe-au-lait, tattoos; culaneous lesions including verrucae, skin tags, keratoses and plaques.
Gasteroenterology - indications for hemostasis in the gastrointestinal tract including varices, esophagitis, esophageal uicer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erostons. Indications for tissue ablation in the gastrointestinal tract including benign and malignant neoplasms, anglodysplassia, polyps, uicers, collitis and hemormoids. Indications for esophageal neoplastic obstructions including squarnous cell carcinoma and adenocarcinoma.
General Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue in endoscopic or open procedures.
Gynecology - indications include vaporization, incision and coagulation of tissue associated with treatments for conditions such as endometriosis; carvical, vulvar and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions and submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, excision ablation and vessel hemostasis.
Neurosurgery - indications include incision, excision, coagulation and vaportzation, of neurosurgical turnors of the firm, textured type.
Ophthalmology - indications include post-vitrectorny endophotocoagulation of the retina.
Plastic Surgery - indications include vaporization, coagulation, incision, excision, debutking and ablation of soft tissue in endoscopic and open procedures. ----------
Spinal Surgery - indications include percutaneous lumbar discectorny.
Thoracic Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue, including lung tissue in thoracoscopic or open procedures.
Urology - indications include cutting, coagulation or vaporization of soft tissue dunk urologic procedures.
Division Sign-Off
Division of General Restorative Devices
510(k) Number K970448
5
Indications for Use Statement, Page 2
Nd:YAG/1064 Applications:
Dermatology - indications include photocoagulation of pigmented vascular lesions to reduce lesion size: for patients with lesions that would potentially benefit from aggressive treatment; and for patients with lesions that have not responded to other laser treatments.
Gasteroenterology - indications for hemostasis in the gastrointestinal tract, including varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric uicer, anoiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erosions. Indications for tissue ablation in the gastrointestinal tract including benign and mallgnant neoplasms, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Indications for esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma.
General Surgery - indications include cutting, ablation and/or hemostasis of soft tissue in endoscopic/laparoscopic and open general surgical applications, including cholecystectorny. appendectorny, vagotomy and pyloromyotomy. Soft tissue general surgical indications include skin incision, tissue dissection, excision of external turnors and lessions, tissue ablation, vessel coaculation and complete or partial resection of internal organs, turnors and lesions.
Genecology - indications include treatment of menormagia by photocoagulation of the endometrial lining of the uterus; ablation of endometrial implants and/or peritoneal adhesions: soft tissue excisional procedures, such as excision of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated, including submucous fibroids, benign endometrial polyps and uterine septum.
Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, exclision, ablation and vessel hemostasis.
Hemostasis During Surgery - indications include adjunctive coaculation and hemostasis (bleeding control) during surgery in endoscopic and epen procedures.
Neurosurgery - indications include hemostasis for pituitary turnor. meningloma. hemoglioblastoma. AVMs. diloblastoma. astrocytoma and oligodendroglioma.
Oculoplastics - indications include incision, excision and/or coagulation of tissue in oculoplastic procedures such as operations on the lacrimal system, operations on the evelids, removal or biopsy of orbital turnors, enucleation of eyeball, exemeration of orbital contents.
Orthopedics - indications include cutting, ablation and/or hemostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications.
Plastic Surgery - indications include cutting, incision, coagulation and vaporization of ... ... soft tissue.
Pulmonary Surgery - indications include palliative procedures for benign and mallignant pulmonary airway obstructions, including squarnous cell carcinoma, carcinoma, carcinoid. benign turnors, granulomas, tracheal stenosis and benion strictures.
Thoracic Surgery - indications incision, excision, excision, coagulation and vaportzation of soft tissue. Thoracic applications, including isolation of vessels for endarterectorny and/or bypass grafts, wedge resections, thoracotomy, formation of pacemaker pockets, vaporization, coagulation, incision, excision debulking and aprilion of lung tissue (thoracoscopy).
scosley e
(Division Sign-Off)
Division of General Restorative Devices K970448
510(k) Number
6
Indications for Use Statement, Page 3
Urology - Indications include superficial urinary bladder turnors, invasive bladder carcinoma. urethreal strictures, bladder neck contracture, diverticulum and lesions of the external genitalia (including condyloma acuminata).
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices/920948
510(k) Number
Prescription Use
(per 21 CFR 801.109)
or
Over-The-Counter Use