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FDA 510(k)

OPTILINK(TM) LPM (LASER POWER MODULATOR)

K-Number: K924166 · 1993-02-05

ApplicantXintec Corporation
Decision Date1993-02-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILINK(TM) LPM (LASER POWER MODULATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K924166. 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 OPTILINK(TM) LPM (LASER POWER MODULATOR)?

OPTILINK(TM) LPM (LASER POWER MODULATOR) is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is Xintec Corporation. The 510(k) number is K924166.

When did OPTILINK(TM) LPM (LASER POWER MODULATOR) receive FDA 510(k) clearance?

OPTILINK(TM) LPM (LASER POWER MODULATOR) received FDA 510(k) clearance on 1993-02-05, under 510(k) number K924166.

Who is the listed applicant for OPTILINK(TM) LPM (LASER POWER MODULATOR)?

The FDA 510(k) record lists Xintec Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTILINK(TM) LPM (LASER POWER MODULATOR)?

The FDA product code for OPTILINK(TM) LPM (LASER POWER MODULATOR) is GEX. This falls under the Gastroenterology category.

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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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