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FDA 510(k)

ACL-5500 PRECISION CURING UNIT (PCU)

K-Number: K953898 · 1996-02-15

ApplicantIon Laser Technology
Decision Date1996-02-15
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACL-5500 PRECISION CURING UNIT (PCU) 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 1996-02-15 under 510(k) number K953898. 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 ACL-5500 PRECISION CURING UNIT (PCU)?

ACL-5500 PRECISION CURING UNIT (PCU) is a medical device that received FDA 510(k) clearance on 1996-02-15. The listed applicant is Ion Laser Technology. The 510(k) number is K953898.

When did ACL-5500 PRECISION CURING UNIT (PCU) receive FDA 510(k) clearance?

ACL-5500 PRECISION CURING UNIT (PCU) received FDA 510(k) clearance on 1996-02-15, under 510(k) number K953898.

Who is the listed applicant for ACL-5500 PRECISION CURING UNIT (PCU)?

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 ACL-5500 PRECISION CURING UNIT (PCU)?

The FDA product code for ACL-5500 PRECISION CURING UNIT (PCU) 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 9500K964524ILT ARGON HPK954460ILT SURGICAL LASERK950351CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)K944317GENESIS 2000K944206GENESIS 2000

View all 9 devices →

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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