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FDA 510(k)

SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940

K-Number: K952661 · 1995-10-06

ApplicantSurgical Laser Technologies, Inc.
Decision Date1995-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 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 1995-10-06 under 510(k) number K952661. 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 THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940?

SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K952661.

When did SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 receive FDA 510(k) clearance?

SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 received FDA 510(k) clearance on 1995-10-06, under 510(k) number K952661.

Who is the listed applicant for SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940?

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 THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940?

The FDA product code for SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 is GEX. This falls under the Gastroenterology category.

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Other records listing Surgical Laser Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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