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Discovery Pico +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K240983

by Quanta System Spa

Identifiers

510(k) Number
K240983 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
Discovery Pico FDA 510(k)EUDAMED
Discovery Pico Plus FDA 510(k)EUDAMED
Discovery Pico Derm FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Discovery Pico series comprises handheld, battery-powered devices designed for laser hair removal and skin rejuvenation, classified under the General, Plastic Surgery advisory committee category. These devices emit pulsed light energy to target hair follicles and improve skin texture, with variations tailored for different skin types and treatment areas, including facial and body applications.

The Discovery Pico and its variants are single-use devices intended for office-based use by trained professionals. Supplied sterile in a sealed pouch, they require no additional preparation beyond connection to the included battery pack. Each model adheres to FDA 510(k) clearance and MDD compliance, with no MRI safety restrictions noted. Storage instructions specify protection from extreme temperatures and direct sunlight, and devices must be discarded after a single use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quanta System Spa

Sources (2)

  • FDA 510(k) K240983 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026