Cleared Traditional

Plasmage System (K202106) - FDA 510(k) Clearance

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

K202106 · Brera Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
616d
Days
Class 2
Risk

K202106 is an FDA 510(k) clearance for the Plasmage 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 Brera Medical, Inc. (Northwood, US). The FDA issued a Cleared decision on April 6, 2022 after a review of 616 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 Brera Medical, Inc. devices

Submission Details

510(k) Number K202106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date April 06, 2022
Days to Decision 616 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
501d slower than avg
Panel avg: 115d · This submission: 616d
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 705
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K202106.
SILKRO
K210084 · Hironic Co., Ltd. · Jun 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
K211652 · Apyx Medical Corporation(Formerly Bovie Medical Corporation) · May 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · Stryker Sustainability Solutions · May 2022
PLEXR PLUS
K210693 · Gmv S.R.L. · Mar 2022
TempSure System
K212891 · Cynosure, LLC · Mar 2022
Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps
K210315 · Modern Medical Equipment Manufacturing, Ltd. · Mar 2022