(89 days)
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No
The document describes a laser system for soft tissue procedures and does not mention any AI or ML components in its description or intended use.
Yes
The device is used for medical procedures like cutting, vaporizing, and coagulating soft tissue for therapeutic purposes (e.g., surgery).
No
Explanation: The device is indicated for cutting, vaporizing, and coagulating soft tissue, which are therapeutic functions. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly outlines a physical laser system with hardware components such as a console, power supplies, lasers, cooling mechanism, keypad control panel, articulating arm, and handpiece adapters. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a laser system for surgical procedures involving cutting, vaporizing, and coagulating soft tissue on the patient.
- Device Description: The device description details a laser system with components for generating and delivering a laser beam for surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body), such as blood, urine, tissue biopsies, etc. IVDs are designed to provide information about a patient's health status through the examination of these types of samples.
Therefore, the Laserscope Erbium:YAG Laser System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Clinical Applications:
Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry
Product codes
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Device Description
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissibate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium: YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 5 mm.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
SEO Medical Trilase 2490
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ERBIUM:YAG LASER SYSTEM AND ACCESSORIES
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
JAN * 8 1997
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 Phone: 408 943-0636 FAX: 408 943-1454
DEVICE TRADE NAME:
Laserscope Erbium: YAG Laser System and Accessories
DEVICE COMMON NAME:
Erbium:YAG Laser System
DEVICE DESCRIPTION:
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissibate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium: YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 5 mm.
Laserscope Premarket Notification for Erbium:YAG Laser System and Accessories
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
Erbium:YAG Laser Systems and Accessories have not been specifically classified; however Nd:YAG, CO₂, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
All Laserscope Erbium:YAG Surgical Laser Systems and Accessories conform with federal requlations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATION FOR USE STATEMENT:
The Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue.
All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Clinical Applications:
Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry
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SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 3
COMPARISON WITH PREDICATE DEVICE:
The Laserscope Erbium: YAG Laser System and Accessories is substantially equivalent to the SEO Medical Trilase 2490.
The risks and benefits for the Laserscope Erbium: YAG Laser System and Accessories are comparable to the predicate device when used for similar clinical applications.
Since the Laserscope Erbium:YAG Laser System and Accessories are 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.