DeviceClearance

Acne Light Therapy Wand— 510(k) K160691

Substantially Equivalent

Zuko, Inc.

FDA 510(k) clearance K160691 for Acne Light Therapy Wand, Substantially Equivalent on 2016-06-21. Applicant: Zuko, Inc.. Device class: 2.

Clearance details

Applicant
Zuko, Inc.
Product code
Code OLP
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wayne, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code OLP

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Adverse events under product code OLP

product code OLP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.