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FDA 510(k)

ILT ARGON HP

K-Number: K964524 · 1997-03-18

ApplicantIon Laser Technology
Decision Date1997-03-18
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ILT ARGON HP 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 1997-03-18 under 510(k) number K964524. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILT ARGON HP?

ILT ARGON HP is a medical device that received FDA 510(k) clearance on 1997-03-18. The listed applicant is Ion Laser Technology. The 510(k) number is K964524.

When did ILT ARGON HP receive FDA 510(k) clearance?

ILT ARGON HP received FDA 510(k) clearance on 1997-03-18, under 510(k) number K964524.

Who is the listed applicant for ILT ARGON HP?

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 ILT ARGON HP?

The FDA product code for ILT ARGON HP is EBZ.

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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 9500K953898ACL-5500 PRECISION CURING UNIT (PCU)K954460ILT SURGICAL LASERK950351CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)K944317GENESIS 2000K944206GENESIS 2000

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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