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FDA 510(k)

SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)

K-Number: K890174 · 1989-01-26

ApplicantSurgical Laser Technologies, Inc.
Decision Date1989-01-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) 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 1989-01-26 under 510(k) number K890174. 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 CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)?

SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) is a medical device that received FDA 510(k) clearance on 1989-01-26. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K890174.

When did SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) receive FDA 510(k) clearance?

SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) received FDA 510(k) clearance on 1989-01-26, under 510(k) number K890174.

Who is the listed applicant for SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)?

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 CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)?

The FDA product code for SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION) 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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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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