Discovery Pico, Discovery Pico Plus, Discovery Pico Derm— 510(k) K191842

Name: FDA 510(k) clearance K191842
Creator: U.S. Food and Drug Administration
Published: 2019-09-17

Substantially Equivalent

Quanta System Spa

FDA 510(k) clearance K191842 for Discovery Pico, Discovery Pico Plus, Discovery Pico Derm, Substantially Equivalent on 2019-09-17. Applicant: Quanta System Spa. Device class: 2.

Clearance details

Applicant: Quanta System Spa
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2019-07-09
Decision date: 2019-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Samarate, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

K241973 — SmartIPL_NI System2026-09-19
K252723 — Dynamis Pro Family2026-09-19
K261047 — Dental Diode Laser Device (Laser-Pen)2026-09-18
K261673 — LED Therapy Device (QLXY-01)2026-09-17
K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)2026-09-17

More clearances from Quanta System Spa

view all

K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm2025-06-06
K243588 — Single Use CO2 Laser Fiber (HAF005001)2025-02-19
K241092 — Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT2024-10-10
K242251 — Litho 60; Litho 100; Litho 1502024-09-03
K232236 — Echo2023-10-20

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.