Cleared Special

Legend X Platform

K252576 · Pollogen, Ltd. · Neurology

Sep 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K252576 is an FDA 510(k) clearance for the Legend X Platform, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on September 12, 2025, 29 days after receiving the submission on August 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K252576 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 2025
Decision Date	September 12, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).