PDZClass II

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

General, Plastic Surgery · 21 CFR 878.4810

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

MDR events3All time

Recalls1All time

Registered firms25Currently listed

510(k) clearances19All time

Recent MDR events

3 adverse event reports on file

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Event type breakdown

No answer provided2

Injury1

Most-reported manufacturers

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Unspecified2 Syneron Medical Ltd.1

Recalls

1 recall events for this product code

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Hyperion Medical
TerminatedAug 18, 2014
All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the pro
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
Z-2264-2014 · View FDA record ↗

Registered firms

25 firms currently registered for this product code

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510(k) clearances

19 clearances for this product code

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