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FDA 510(k)

SDL DIODE LASER SYSTEM

K-Number: K960905 · 1996-06-03

ApplicantSlt-J , Ltd.
Decision Date1996-06-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SDL DIODE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Slt-J , Ltd.. It received FDA 510(k) clearance on 1996-06-03 under 510(k) number K960905. 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 SDL DIODE LASER SYSTEM?

SDL DIODE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-03. The listed applicant is Slt-J , Ltd.. The 510(k) number is K960905.

When did SDL DIODE LASER SYSTEM receive FDA 510(k) clearance?

SDL DIODE LASER SYSTEM received FDA 510(k) clearance on 1996-06-03, under 510(k) number K960905.

Who is the listed applicant for SDL DIODE LASER SYSTEM?

The FDA 510(k) record lists Slt-J , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDL DIODE LASER SYSTEM?

The FDA product code for SDL DIODE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Slt-J , Ltd. 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.

K964031DCL8 ENHANCED PULSED ND:YAG LASER SYSTEMK960086DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM

Related Devices (Code: GEX)

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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.

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