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FDA 510(k)

KAVO KEY LASER 1242

K-Number: K983100 · 1999-01-27

ApplicantKavo America
Decision Date1999-01-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KAVO KEY LASER 1242 is the device name listed in this FDA 510(k) record. The listed applicant is Kavo America. It received FDA 510(k) clearance on 1999-01-27 under 510(k) number K983100. 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 KAVO KEY LASER 1242?

KAVO KEY LASER 1242 is a medical device that received FDA 510(k) clearance on 1999-01-27. The listed applicant is Kavo America. The 510(k) number is K983100.

When did KAVO KEY LASER 1242 receive FDA 510(k) clearance?

KAVO KEY LASER 1242 received FDA 510(k) clearance on 1999-01-27, under 510(k) number K983100.

Who is the listed applicant for KAVO KEY LASER 1242?

The FDA 510(k) record lists Kavo America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAVO KEY LASER 1242?

The FDA product code for KAVO KEY LASER 1242 is GEX. This falls under the Gastroenterology category.

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Other records listing Kavo America 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.

K073074KEY LASER III 1243 US WITH DETECTK072262GENTLERAY 980 DIODE LASER SYSTEMK063624KAVO EVEREST C-TEMPK051909DIAGNODENTK030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+K050019IN EXAM INTRAORAL DENTAL X-RAY 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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