DeviceClearance

SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories— 510(k) K221306

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K221306 for SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories, Substantially Equivalent on 2023-01-27. 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
Traditional
Location
Westborough, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEX

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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 K221306

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 K221306.

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