Cleared Traditional

K180999 - Mygen V-1000 RF System

K180999 is an FDA 510(k) clearance for Mygen V-1000 RF System, manufactured by RF Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K180999 · RF Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
239d
Days
Class 2
Risk

K180999 is an FDA 510(k) clearance for the Mygen V-1000 RF 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 RF Medical Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on December 11, 2018 after a review of 239 days - an extended review 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. 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 RF Medical Co., Ltd. devices

FDA 510(k) Submission Details - K180999

510(k) Number K180999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2018
Decision Date December 11, 2018
Days to Decision 239 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1258
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K180999.
SafeAir Telescopic Smoke Pencil
K182354 · Lina Medical Aps · Dec 2018
BTL-FR2000
K180359 · BTL Industries, Inc. · Dec 2018
Medline Cautery Electrode (SILICONE)
K182812 · Medline Industries, Inc. · Dec 2018
LUTRONIC GENIUS Radiofrequency System
K180945 · Lutronic Corporation · Dec 2018
Device Electrosurgical Generator ESG-150
K182587 · Olympus Winter & Ibe GmbH · Nov 2018
Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
K182801 · Integra LifeSciences Corporation · Nov 2018