Cleared Traditional

K240983 - Discovery Pico

Also marketed or referenced as:
Discovery Pico Plus Discovery Pico Derm

K240983 is the FDA 510(k) clearance for Discovery Pico 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 422-day FDA review.

K240983 · Quanta System Spa · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
422d
Days
Class 2
Risk

K240983 is an FDA 510(k) clearance for the Discovery Pico. 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 June 6, 2025 after a review of 422 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 878.4810 - 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: 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 Quanta System Spa devices

Submission Details

510(k) Number K240983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2024
Decision Date June 06, 2025
Days to Decision 422 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
307d slower than avg
Panel avg: 115d · This submission: 422d
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 K240983.
Fractional CO2 Laser Machine
K250782 · Zhengzhou PZ Laser Slim Technology Co., Ltd. · Jun 2025
Q-Switched Nd:YAG Laser (SHE-LSP101-1)
K250936 · Beijing Sano Laser S&T Development Co.,Ltd · Jun 2025
CO2 Laser Machine (Lume)
K250465 · Nanjing Bestview Laser S&T Co., Ltd. · Jun 2025
Nd: YAG Laser Therapy System (QN-1)
K250722 · Hebei JT Medical Co., Ltd. · Jun 2025
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
K250195 · Matelaser, Inc. · May 2025
The Alma Hybrid Laser System
K251230 · Alma Lasers, Inc. · May 2025