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FDA 510(k)

KEY LASER III 1243 US WITH DETECT

K-Number: K073074 · 2008-07-10

ApplicantKavo America
Decision Date2008-07-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KEY LASER III 1243 US WITH DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Kavo America. It received FDA 510(k) clearance on 2008-07-10 under 510(k) number K073074. 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 KEY LASER III 1243 US WITH DETECT?

KEY LASER III 1243 US WITH DETECT is a medical device that received FDA 510(k) clearance on 2008-07-10. The listed applicant is Kavo America. The 510(k) number is K073074.

When did KEY LASER III 1243 US WITH DETECT receive FDA 510(k) clearance?

KEY LASER III 1243 US WITH DETECT received FDA 510(k) clearance on 2008-07-10, under 510(k) number K073074.

Who is the listed applicant for KEY LASER III 1243 US WITH DETECT?

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 KEY LASER III 1243 US WITH DETECT?

The FDA product code for KEY LASER III 1243 US WITH DETECT 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.

K072262GENTLERAY 980 DIODE LASER SYSTEMK063624KAVO EVEREST C-TEMPK051909DIAGNODENTK030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+K050019IN EXAM INTRAORAL DENTAL X-RAY SYSTEMK032081KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

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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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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