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K Number
K023257
Device Name
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
Manufacturer
PROSURG, INC.
Date Cleared
2003-03-28

(179 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indications For Use:

Endoscopic Laser Delivery System -LaserTx

The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue.

The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Endoscopic Laser Delivery System - LaserTx." This document confirms the device's substantial equivalence to previously marketed devices and outlines regulatory requirements.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The letter focuses on regulatory approval based on equivalence and not on specific performance metrics or clinical study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

§ 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.