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FDA 510(k)

MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL

K-Number: K900539 · 1990-05-03

ApplicantSunrise Technologies, Inc.
Decision Date1990-05-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL 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 1990-05-03 under 510(k) number K900539. 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 DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL?

MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL is a medical device that received FDA 510(k) clearance on 1990-05-03. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K900539.

When did MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL receive FDA 510(k) clearance?

MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL received FDA 510(k) clearance on 1990-05-03, under 510(k) number K900539.

Who is the listed applicant for MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL?

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 DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL?

The FDA product code for MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL is GEX. This falls under the Gastroenterology category.

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Other records listing Sunrise Technologies, Inc. as applicant

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Related Devices (Code: GEX)

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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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