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FDA 510(k)

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER

K-Number: K902562 · 1990-06-20

ApplicantLca, Inc.
Decision Date1990-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Lca, Inc.. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K902562. 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 REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER?

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Lca, Inc.. The 510(k) number is K902562.

When did REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER receive FDA 510(k) clearance?

REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER received FDA 510(k) clearance on 1990-06-20, under 510(k) number K902562.

Who is the listed applicant for REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER?

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

What is the FDA product code for REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER?

The FDA product code for REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Lca, Inc. as applicant

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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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