Cleared Traditional

K211228 - Rosso

K211228 is the FDA 510(k) clearance for Rosso by Quanta System Spa. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K211228 · Quanta System Spa · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2022
Decision
285d
Days
Class 2
Risk

K211228 is an FDA 510(k) clearance for the Rosso. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Quanta System Spa (Samarate, IT). The FDA issued a Cleared decision on February 2, 2022 after a review of 285 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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 Quanta System Spa devices

Submission Details

510(k) Number K211228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2021
Decision Date February 02, 2022
Days to Decision 285 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
170d slower than avg
Panel avg: 115d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 - GEX Powered Laser Surgical Instrument

All 1170
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K211228.
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
K211722 · Canadian Pioneer Medical Technology Corporation · Feb 2022
HOLLYWOOD SPECTRA Laser System
K213569 · Lutronic Corporation · Feb 2022
Cryo 7
K220020 · Zimmer Medizinsysteme GmbH · Feb 2022
Sentient Manufacturing Laser Fiber
K213554 · Sentient Manufacturing , LLC · Feb 2022
CO2 Laser Equipment
K212611 · Beijing Globalipl Development Co., Ltd. · Feb 2022
Platform treatment system
K203395 · Shanghai Apolo Medical Technology Co., Ltd. · Jan 2022