DeviceClearance

INPULSE LASER— 510(k) K131805

Substantially Equivalent

Incisive, Inc.

FDA 510(k) clearance K131805 for INPULSE LASER, Substantially Equivalent on 2013-07-18. Applicant: Incisive, Inc.. Device class: 2.

Clearance details

Applicant
Incisive, Inc.
Product code
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
Special
Location
Homosassa, FL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEX

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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.