Cleared Traditional

K090025 - MATRIX RF APPLICATOR

K090025 is the FDA 510(k) clearance for MATRIX RF APPLICATOR by Syneron Medical, Ltd.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K090025 · Syneron Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
368d
Days
Class 2
Risk

K090025 is an FDA 510(k) clearance for the MATRIX RF APPLICATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Syneron Medical, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on January 8, 2010 after a review of 368 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Syneron Medical, Ltd. devices

Submission Details

510(k) Number K090025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2009
Decision Date January 08, 2010
Days to Decision 368 days
Submission Type Traditional
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
253d slower than avg
Panel avg: 115d · This submission: 368d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00887913 Completed Interventional Industry-sponsored

Clinical Study to Evaluate the Performance of Fractional Radiofrequency for Improvement of Skin Texture Via Skin Resurfacing and Wrinkles Reduction

69
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Skin Resurfacing; Wrinkle Reduction
Study design Single group
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Sponsor Syneron Medical (industry)
Started 2008-04-01 → Primary completion 2008-12-01 → Completed 2009-10-01
Primary outcome
Improvement in Fine Lines
View full study on ClinicalTrials.gov

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 K090025.
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
K093203 · Medtronic, Inc. · Feb 2010
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc. · Jan 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp. · Jan 2010
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · Arthrocare Corp. · Dec 2009
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
K091824 · Ethicon Endo-Surgery, Inc. · Nov 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
K092009 · Boston Scientific Corporation · Nov 2009