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FDA 510(k)

INPULSE DENTAL LASER

K-Number: K011423 · 2001-08-07

ApplicantIncisive, LLC
Decision Date2001-08-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INPULSE DENTAL LASER is the device name listed in this FDA 510(k) record. The listed applicant is Incisive, LLC. It received FDA 510(k) clearance on 2001-08-07 under 510(k) number K011423. 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 INPULSE DENTAL LASER?

INPULSE DENTAL LASER is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is Incisive, LLC. The 510(k) number is K011423.

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

INPULSE DENTAL LASER received FDA 510(k) clearance on 2001-08-07, under 510(k) number K011423.

Who is the listed applicant for INPULSE DENTAL LASER?

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

What is the FDA product code for INPULSE DENTAL LASER?

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

Related Clinical Trials

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Other records listing Incisive, LLC 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.

K083215INCISIVE FAMILY OF INPULSE ND:YAG LASERS

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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