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FDA 510(k)

UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER

K-Number: K931774 · 1993-07-22

ApplicantSunrise Technologies, Inc.
Decision Date1993-07-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER 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 1993-07-22 under 510(k) number K931774. 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 UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER?

UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K931774.

When did UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER receive FDA 510(k) clearance?

UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER received FDA 510(k) clearance on 1993-07-22, under 510(k) number K931774.

Who is the listed applicant for UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER?

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 UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER?

The FDA product code for UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER 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)

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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