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FDA 510(k)

MODEL 20 KY KRYPTON YELLOW LASER

K-Number: K881940 · 1988-07-20

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1988-07-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 20 KY KRYPTON YELLOW LASER is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1988-07-20 under 510(k) number K881940. 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 MODEL 20 KY KRYPTON YELLOW LASER?

MODEL 20 KY KRYPTON YELLOW LASER is a medical device that received FDA 510(k) clearance on 1988-07-20. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K881940.

When did MODEL 20 KY KRYPTON YELLOW LASER receive FDA 510(k) clearance?

MODEL 20 KY KRYPTON YELLOW LASER received FDA 510(k) clearance on 1988-07-20, under 510(k) number K881940.

Who is the listed applicant for MODEL 20 KY KRYPTON YELLOW LASER?

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

What is the FDA product code for MODEL 20 KY KRYPTON YELLOW LASER?

The FDA product code for MODEL 20 KY KRYPTON YELLOW LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm Medical Laser Systems, 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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