Cleared Traditional

Pollogen Legend+ System (K171359) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171359 · Pollogen, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
127d
Days
Class 2
Risk

K171359 is an FDA 510(k) clearance for the Pollogen Legend+ System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on September 13, 2017 after a review of 127 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pollogen, Ltd. devices

Submission Details

510(k) Number K171359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date September 13, 2017
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 620
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K171359.
gi-4000 Electrosurgical Generator
K172805 · United States Endoscopy Group, Inc. · Oct 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation · Oct 2017
TempSure
K171262 · Cynosure, Inc. · Sep 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · Stryker Instruments · Aug 2017
AUTOCON III 400
K171717 · KARL STORZ Endoscopy-America, Inc. · Aug 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · Covidien, LLC · Jun 2017