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FDA 510(k)

MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS

K-Number: K042211 · 2004-11-08

ApplicantSurgical Laser Technologies, Inc.
Decision Date2004-11-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS 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 2004-11-08 under 510(k) number K042211. 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 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS?

MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-11-08. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K042211.

When did MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS receive FDA 510(k) clearance?

MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS received FDA 510(k) clearance on 2004-11-08, under 510(k) number K042211.

Who is the listed applicant for MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS?

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 MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS?

The FDA product code for MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS 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.

K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEMK010041SLT DIFFUSER FIBERK984018HEMOSLEEVE, MODEL 4.0MM, 5.5MMK983050PNEUMATIC CUTTER SYSTEMK981041SLT BIPOLAR SHEATH

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Related Devices (Code: GEX)

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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