Cleared Special

K252740 - Voyant Open Fusion Device (EB240/Open F...

K252740 is the FDA 510(k) clearance for Voyant Open Fusion Device (EB240/Open F... by Applied Medical Resources Corp.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 68-day FDA review.

K252740 · Applied Medical Resources Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
68d
Days
Class 2
Risk

K252740 is an FDA 510(k) clearance for the Voyant® Open Fusion Device (EB240/Open Fusion). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on November 4, 2025 after a review of 68 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Applied Medical Resources Corp. devices

Submission Details

510(k) Number K252740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2025
Decision Date November 04, 2025
Days to Decision 68 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K252740.
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
K252704 · F Care Systems USA, LLC · Nov 2025
TS-RF Generator (STS10)
K251566 · Starmed Co., Ltd. · Nov 2025
Venus Nova (FP-2001)
K252845 · Venus Concept, Inc. · Nov 2025
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
K252412 · Applied Medical Resources Corporation · Oct 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275 · Baylis Medical Technologies, Inc. · Oct 2025
ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)
K250126 · Livsmed, Inc. · Oct 2025