Accelawave System

FDA 510(k) K082484 · Genesis Biosystems, Inc.

Substantially Equivalent

510(k) numberK082484

Submission

Device name
Accelawave System
Applicant
Genesis Biosystems, Inc.
Lewisville, TX, US
Received
August 28, 2008
Decision date
September 12, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Specialty
General, Plastic Surgery

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon…

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K240482Intense Pulsed Light System (ST-690)ONF · Traditional Smedtrum Medical Technology Co., Ltd.05/17/2024SE
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K233307Intensity Pulsed Light Therapy SystemONF · Traditional Beijing Adss Development Co., Ltd.03/15/2024SE

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Questions and answers

When was Accelawave System cleared by the FDA?

Accelawave System (K082484) received a 510(k) decision of Substantially Equivalent on September 12, 2008, 15 days after the submission was received.

What is the product code of K082484?

The FDA product code is ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, a Class II (moderate risk) device regulated under 21 CFR 878.4810.