inforMED
OLPClass II

Over-the-counter Powered Light Based Laser For Acne

General, Plastic Surgery · 21 CFR 878.4810

The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

MDR events51All time
Recalls4All time
Registered firms191Currently listed
510(k) clearances51All time

Recent MDR events

51 adverse event reports on file

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Event type breakdown

Injury44
Malfunction5
Death1
Other1

Most-reported manufacturers

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Johnson & Johnson Consumer Inc28Johnson & Johnson Consumer Inc.8Kinseng Plastics Co. Ltd.5Unspecified1Aesthetic Technology Ltd1Globalmed Technologies Co.1Johnson And Johnson Consumer Inc.1La Lumiere, Llc1

Recalls

4 recall events for this product code

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Registered firms

191 firms currently registered for this product code

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510(k) clearances

51 clearances for this product code

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