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FDA 510(k)

WATERLASE MILLENNIUM

K-Number: K012511 · 2002-01-18

ApplicantBiolase Technology, Inc.
Decision Date2002-01-18
Product CodeMXF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WATERLASE MILLENNIUM 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 2002-01-18 under 510(k) number K012511. The device is classified under product code MXF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATERLASE MILLENNIUM?

WATERLASE MILLENNIUM is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K012511.

When did WATERLASE MILLENNIUM receive FDA 510(k) clearance?

WATERLASE MILLENNIUM received FDA 510(k) clearance on 2002-01-18, under 510(k) number K012511.

Who is the listed applicant for WATERLASE MILLENNIUM?

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 WATERLASE MILLENNIUM?

The FDA product code for WATERLASE MILLENNIUM is MXF.

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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.

K122368WATERLASE IPLUS ALL TISSUE LASERK130465EPIC 10SK121327DIOLASE 10SK121286EPIC 10K101658WATERLASE MD TURBO PLUS MODEL 7200XXXK093852EZLASE 3 LASER SYSTEM

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Related Devices (Code: MXF)

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.

K022803WATERLASE FOR APICOECTOMYBiolase Technology, Inc.K013908WATERLASE MILLENNIUMBiolase Technology, Inc.K990908MILLENNIUMEndo Technic Corp.K990219MODIFICATION OF MILLENNIUMBiolase Technology, Inc.

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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