FDA 510(k)

SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)

K-Number: K950819 · 1995-04-18

ApplicantSurgical Laser Technologies, Inc.

Decision Date1995-04-18

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K950819. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)?

SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K950819.

When did SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) receive FDA 510(k) clearance?

SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) received FDA 510(k) clearance on 1995-04-18, under 510(k) number K950819.

Who is the listed applicant for SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)?

The FDA 510(k) record lists Surgical Laser Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)?

The FDA product code for SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) is GEX. This falls under the Gastroenterology category.

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Other records listing Surgical Laser Technologies, Inc. as applicant

K042211MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEM K010041SLT DIFFUSER FIBER K984018HEMOSLEEVE, MODEL 4.0MM, 5.5MM K983050PNEUMATIC CUTTER SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.