inforMED
ONFClass II

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

General, Plastic Surgery · 21 CFR 878.4810

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 laser intended to cut, destroy, or remove tissue by the light.

MDR events33All time
Recalls0All time
Registered firms156Currently listed
510(k) clearances74All time

Recent MDR events

33 adverse event reports on file

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Event type breakdown

Injury30
Malfunction3

Most-reported manufacturers

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Shaser Inc9Inmode Ltd.4Sciton, Inc.3Venus Concept Ltd3Shaser, Inc2Unknown2Ellipse A/s1Inmode Ltd1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

156 firms currently registered for this product code

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510(k) clearances

74 clearances for this product code

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