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FDA 510(k)

HEXASCAN HANDPIECE FOR ARGON/DYE LASER

K-Number: K884431 · 1988-12-02

ApplicantCalifornia Laboratories, Inc.
Decision Date1988-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEXASCAN HANDPIECE FOR ARGON/DYE LASER is the device name listed in this FDA 510(k) record. The listed applicant is California Laboratories, Inc.. It received FDA 510(k) clearance on 1988-12-02 under 510(k) number K884431. 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 HEXASCAN HANDPIECE FOR ARGON/DYE LASER?

HEXASCAN HANDPIECE FOR ARGON/DYE LASER is a medical device that received FDA 510(k) clearance on 1988-12-02. The listed applicant is California Laboratories, Inc.. The 510(k) number is K884431.

When did HEXASCAN HANDPIECE FOR ARGON/DYE LASER receive FDA 510(k) clearance?

HEXASCAN HANDPIECE FOR ARGON/DYE LASER received FDA 510(k) clearance on 1988-12-02, under 510(k) number K884431.

Who is the listed applicant for HEXASCAN HANDPIECE FOR ARGON/DYE LASER?

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

What is the FDA product code for HEXASCAN HANDPIECE FOR ARGON/DYE LASER?

The FDA product code for HEXASCAN HANDPIECE FOR ARGON/DYE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing California Laboratories, 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)

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Official Source

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