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FDA 510(k)

DENTAL LASER FIBER SYSTEM

K-Number: K945143 · 1994-11-01

ApplicantIncisive Technologies, Inc.
Decision Date1994-11-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENTAL LASER FIBER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Incisive Technologies, Inc.. It received FDA 510(k) clearance on 1994-11-01 under 510(k) number K945143. 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 DENTAL LASER FIBER SYSTEM?

DENTAL LASER FIBER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is Incisive Technologies, Inc.. The 510(k) number is K945143.

When did DENTAL LASER FIBER SYSTEM receive FDA 510(k) clearance?

DENTAL LASER FIBER SYSTEM received FDA 510(k) clearance on 1994-11-01, under 510(k) number K945143.

Who is the listed applicant for DENTAL LASER FIBER SYSTEM?

The FDA 510(k) record lists Incisive Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL LASER FIBER SYSTEM?

The FDA product code for DENTAL LASER FIBER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Incisive 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.

K943693PULSEMASTER S SERIESK942217PULSEJET DENTAL LASER SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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