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FDA 510(k)

SLASE 210 PLUS HOLMIUM LASER SYSTEM

K-Number: K942542 · 1994-09-01

ApplicantSunrise Technologies, Inc.
Decision Date1994-09-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SLASE 210 PLUS HOLMIUM 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 1994-09-01 under 510(k) number K942542. 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 SLASE 210 PLUS HOLMIUM LASER SYSTEM?

SLASE 210 PLUS HOLMIUM LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-09-01. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K942542.

When did SLASE 210 PLUS HOLMIUM LASER SYSTEM receive FDA 510(k) clearance?

SLASE 210 PLUS HOLMIUM LASER SYSTEM received FDA 510(k) clearance on 1994-09-01, under 510(k) number K942542.

Who is the listed applicant for SLASE 210 PLUS HOLMIUM 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 SLASE 210 PLUS HOLMIUM LASER SYSTEM?

The FDA product code for SLASE 210 PLUS HOLMIUM 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.

K962192SUNRISE CURING LAMPK932997MICROPREP CAVITY PREPERATION SYSTEMK933007SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMSK933017MODEL 5030 SUCTION HANDPIECE SYSTEMK931774UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASERK9308792.5 WATT PULSED DENTAL LASER SYSTEM

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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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