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FDA 510(k)

EZLASE

K-Number: K083595 · 2009-04-14

ApplicantBiolase Technology, Inc.
Decision Date2009-04-14
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EZLASE is the device name listed in this FDA 510(k) record. The listed applicant is Biolase Technology, Inc.. It received FDA 510(k) clearance on 2009-04-14 under 510(k) number K083595. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZLASE?

EZLASE is a medical device that received FDA 510(k) clearance on 2009-04-14. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K083595.

When did EZLASE receive FDA 510(k) clearance?

EZLASE received FDA 510(k) clearance on 2009-04-14, under 510(k) number K083595.

Who is the listed applicant for EZLASE?

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

What is the FDA product code for EZLASE?

The FDA product code for EZLASE is ILY.

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Other records listing Biolase Technology, 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.

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Related Devices (Code: ILY)

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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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