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FDA 510(k)

ACCELAWAVE SYSTEM

K-Number: K082484 · 2008-09-12

ApplicantGenesis Biosystems, Inc.
Decision Date2008-09-12
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCELAWAVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Biosystems, Inc.. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K082484. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCELAWAVE SYSTEM?

ACCELAWAVE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Genesis Biosystems, Inc.. The 510(k) number is K082484.

When did ACCELAWAVE SYSTEM receive FDA 510(k) clearance?

ACCELAWAVE SYSTEM received FDA 510(k) clearance on 2008-09-12, under 510(k) number K082484.

Who is the listed applicant for ACCELAWAVE SYSTEM?

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

What is the FDA product code for ACCELAWAVE SYSTEM?

The FDA product code for ACCELAWAVE SYSTEM is ONF.

Related Clinical Trials

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Other records listing Genesis Biosystems, 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.

K172714LipiVageK131142GENESIS LED WANDSK081578ACCELA SYSTEM

Related Devices (Code: ONF)

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., 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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