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FDA 510(k)

ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR

K-Number: K920107 · 1992-03-13

ApplicantSunrise Technologies, Inc.
Decision Date1992-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR 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 1992-03-13 under 510(k) number K920107. 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 ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR?

ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR is a medical device that received FDA 510(k) clearance on 1992-03-13. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K920107.

When did ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR receive FDA 510(k) clearance?

ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR received FDA 510(k) clearance on 1992-03-13, under 510(k) number K920107.

Who is the listed applicant for ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR?

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 ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR?

The FDA product code for ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR is GEX. This falls under the Gastroenterology category.

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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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