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FDA 510(k)

SONICWAVE SONIC PLAQUE REMOVER

K-Number: K012914 · 2001-10-01

ApplicantHomedics, Inc.
Decision Date2001-10-01
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SONICWAVE SONIC PLAQUE REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Homedics, Inc.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K012914. The device is classified under product code JEQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONICWAVE SONIC PLAQUE REMOVER?

SONICWAVE SONIC PLAQUE REMOVER is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Homedics, Inc.. The 510(k) number is K012914.

When did SONICWAVE SONIC PLAQUE REMOVER receive FDA 510(k) clearance?

SONICWAVE SONIC PLAQUE REMOVER received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012914.

Who is the listed applicant for SONICWAVE SONIC PLAQUE REMOVER?

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

What is the FDA product code for SONICWAVE SONIC PLAQUE REMOVER?

The FDA product code for SONICWAVE SONIC PLAQUE REMOVER is JEQ.

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Other records listing Homedics, 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: JEQ)

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.

K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble CompanyK061351ORAL-B SONIC COMPLETEBraun GmbHK061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESBraun GmbHK040416SONICARE ADVANCE TOOTHBRUSH, MODEL 4900Philips Oral Healthcare, Inc.K022900BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHESJohn O. Butler Co.K970381POWERED TOOTHBRUSHEmjoi Action USA, Ltd.

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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