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FDA 510(k)

ILUMA VISION

K-Number: K081347 · 2008-05-28

ApplicantImtec Corp.
Decision Date2008-05-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ILUMA VISION is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K081347. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILUMA VISION?

ILUMA VISION is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Imtec Corp.. The 510(k) number is K081347.

When did ILUMA VISION receive FDA 510(k) clearance?

ILUMA VISION received FDA 510(k) clearance on 2008-05-28, under 510(k) number K081347.

Who is the listed applicant for ILUMA VISION?

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

What is the FDA product code for ILUMA VISION?

The FDA product code for ILUMA VISION is LLZ.

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Other records listing Imtec Corp. 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.

K081653MDI MII ONE-PIECE IMPLANT, 2.9MMK072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114K053046ILUMA ORTHOCAT/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K042289MDI ORTHOK033432LEXATITE QUICK ACRYLIC

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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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