510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211401Substantially Equivalent

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Gyrus ACMI, Inc., Westborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211401 is the FDA 510(k) clearance record for SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), a class II device, cleared for Gyrus Acmi, Inc. on under FDA product code GEX (Powered Laser Surgical Instrument). FDA's definition for product code GEX reads: "A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue...". FDA records list 67 510(k) clearances for Gyrus Acmi, Inc., from to . As of , FDA records show one recall naming K211401.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GEX Powered Laser Surgical Instrument
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gyrus Acmi, Inc. 800 W. Park Dr., Westborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEX

Trailing 12 months
68 clearances under product code GEX in the twelve months to October 2026, November 2025 the highest month at 11.
Show the numbers
Monthly 510(k) clearances under FDA product code GEX, trailing twelve months
MonthClearances
November 202511
December 20255
January 20264
February 20266
March 20267
April 20265
May 20268
June 20263
July 20264
August 20264
September 202611
October 20260