Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPTI-LITE

K-Number: K844351 · 1984-12-21

ApplicantInnovators, Inc.
Decision Date1984-12-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTI-LITE is the device name listed in this FDA 510(k) record. The listed applicant is Innovators, Inc.. It received FDA 510(k) clearance on 1984-12-21 under 510(k) number K844351. 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 OPTI-LITE?

OPTI-LITE is a medical device that received FDA 510(k) clearance on 1984-12-21. The listed applicant is Innovators, Inc.. The 510(k) number is K844351.

When did OPTI-LITE receive FDA 510(k) clearance?

OPTI-LITE received FDA 510(k) clearance on 1984-12-21, under 510(k) number K844351.

Who is the listed applicant for OPTI-LITE?

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

What is the FDA product code for OPTI-LITE?

The FDA product code for OPTI-LITE is EBZ.

Other records listing Innovators, 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.

K921355WINGMASTERK921354BLUNT TIP IRRIGATION NEEDLESK921406SILICONT BUR BLOCKK830042E-Z JECTORK790984KLIP-LITE

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.

↑