DeviceClearance

New Era— 510(k) K182604

Substantially Equivalent

Step UP Skin Laser, LLC

FDA 510(k) clearance K182604 for New Era, Substantially Equivalent on 2018-11-14. Applicant: Step UP Skin Laser, LLC. Device class: 2.

Clearance details

Applicant
Step UP Skin Laser, LLC
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
Traditional
Location
New York, NY, 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 →

Recalls naming K182604

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182604.

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