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FDA 510(k)

LASEGUIDE CAT # CLF-600D & CLF-1000D

K-Number: K901786 · 1990-06-27

ApplicantLaser Peripherals, LLC
Decision Date1990-06-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASEGUIDE CAT # CLF-600D & CLF-1000D is the device name listed in this FDA 510(k) record. The listed applicant is Laser Peripherals, LLC. It received FDA 510(k) clearance on 1990-06-27 under 510(k) number K901786. 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 LASEGUIDE CAT # CLF-600D & CLF-1000D?

LASEGUIDE CAT # CLF-600D & CLF-1000D is a medical device that received FDA 510(k) clearance on 1990-06-27. The listed applicant is Laser Peripherals, LLC. The 510(k) number is K901786.

When did LASEGUIDE CAT # CLF-600D & CLF-1000D receive FDA 510(k) clearance?

LASEGUIDE CAT # CLF-600D & CLF-1000D received FDA 510(k) clearance on 1990-06-27, under 510(k) number K901786.

Who is the listed applicant for LASEGUIDE CAT # CLF-600D & CLF-1000D?

The FDA 510(k) record lists Laser Peripherals, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASEGUIDE CAT # CLF-600D & CLF-1000D?

The FDA product code for LASEGUIDE CAT # CLF-600D & CLF-1000D is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Peripherals, LLC 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.

K170366Laser Peripherals, LLC Family of Bare Laser FibersK030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBERK992083SCATTERFREE LATERAL EMITTING FIBERK974229LS-905 FIBERCHOICE ADAPTER SYSTEMK972272LASER PERIPHERALS HOLMIUM BARE FIBERS

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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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