Cleared Traditional

K121481 - INFINI RADIOFREQUENCY SYSTEM

K121481 is the FDA 510(k) clearance for INFINI RADIOFREQUENCY SYSTEM by Lutronic Corporation. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K121481 · Lutronic Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
403d
Days
Class 2
Risk

K121481 is an FDA 510(k) clearance for the INFINI RADIOFREQUENCY 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 Lutronic Corporation (Trevose, US). The FDA issued a Cleared decision on June 25, 2013 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Lutronic Corporation devices

Submission Details

510(k) Number K121481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date June 25, 2013
Days to Decision 403 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
288d slower than avg
Panel avg: 115d · This submission: 403d
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 1119
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K121481.
ARTHROCARE HEAD AND NECK COBLATION WAND
K131205 · ArthroCare Corporation · Aug 2013
TRANSCEND
K120510 · Syneron Medical, Ltd. · Jul 2013
ARTHROCARE TURBINATOR WAND
K122652 · ArthroCare Corporation · Jul 2013
CIQ CONTROLLER, CIQ WANDS
K123353 · ArthroCare Corporation · Apr 2013
OLYMPUS ENERGY POWER SYSTEM (EPS)
K123429 · Gyrus Acmi, Inc. · Apr 2013
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K130744 · Covidien · Apr 2013