DeviceClearance

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)— 510(k) K211401

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K211401 for SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), Substantially Equivalent on 2021-06-03. Applicant: Gyrus Acmi, Inc.. Device class: 2.

Clearance details

Applicant
Gyrus Acmi, 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
Westborough, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Gyrus Acmi, Inc.

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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 K211401

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 K211401.

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