DeviceClearance

Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family— 510(k) K142924

Substantially Equivalent

Shaser, Inc.

FDA 510(k) clearance K142924 for Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family, Substantially Equivalent on 2015-02-13. Applicant: Shaser, Inc.. Device class: 2.

Clearance details

Applicant
Shaser, Inc.
Product code
Product code GEX
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
Lexington, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

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.