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FDA 510(k)

MODEL DLASER 1000 ND;YAG LASER SYSTEM

K-Number: K914568 · 1991-11-07

ApplicantSunrise Technologies, Inc.
Decision Date1991-11-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL DLASER 1000 ND;YAG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Technologies, Inc.. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K914568. 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 DLASER 1000 ND;YAG LASER SYSTEM?

MODEL DLASER 1000 ND;YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K914568.

When did MODEL DLASER 1000 ND;YAG LASER SYSTEM receive FDA 510(k) clearance?

MODEL DLASER 1000 ND;YAG LASER SYSTEM received FDA 510(k) clearance on 1991-11-07, under 510(k) number K914568.

Who is the listed applicant for MODEL DLASER 1000 ND;YAG LASER SYSTEM?

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

What is the FDA product code for MODEL DLASER 1000 ND;YAG LASER SYSTEM?

The FDA product code for MODEL DLASER 1000 ND;YAG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Sunrise Technologies, 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)

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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