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FDA 510(k)

GENESIS 2000

K-Number: K944206 · 1994-10-11

ApplicantIon Laser Technology
Decision Date1994-10-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENESIS 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Ion Laser Technology. It received FDA 510(k) clearance on 1994-10-11 under 510(k) number K944206. 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 GENESIS 2000?

GENESIS 2000 is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Ion Laser Technology. The 510(k) number is K944206.

When did GENESIS 2000 receive FDA 510(k) clearance?

GENESIS 2000 received FDA 510(k) clearance on 1994-10-11, under 510(k) number K944206.

Who is the listed applicant for GENESIS 2000?

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

What is the FDA product code for GENESIS 2000?

The FDA product code for GENESIS 2000 is GEX. This falls under the Gastroenterology category.

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Other records listing Ion Laser Technology 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.

K974369APOLLO 9500K964524ILT ARGON HPK953898ACL-5500 PRECISION CURING UNIT (PCU)K954460ILT SURGICAL LASERK950351CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)K944317GENESIS 2000

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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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