Medical Device Manufacturer · US , Chelmsford , MA

Quanta System Spa - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 2006

Recent clearances: Discovery Pico, Single Use CO2 Laser Fiber (HAF005001), Youlaser PRIME

57

Total

57

Cleared

0

Denied

FDA 510(k) Regulatory Record - Quanta System Spa General & Plastic Surgery ✕

57 devices

1-12 of 57

Cleared Jun 06, 2025

General & Plastic Surgery · 422d

Cleared Feb 19, 2025

Single Use CO2 Laser Fiber (HAF005001)

General & Plastic Surgery · 91d

Cleared Oct 10, 2024

General & Plastic Surgery · 171d

Cleared Sep 03, 2024

General & Plastic Surgery · 34d

Cleared Oct 20, 2023

General & Plastic Surgery · 85d

Cleared Jan 20, 2023

General & Plastic Surgery · 72d

Cleared Mar 16, 2022

General & Plastic Surgery · 30d

Cleared Feb 02, 2022

General & Plastic Surgery · 285d

Cleared Mar 11, 2021

General & Plastic Surgery · 51d

Cleared Nov 18, 2020

General & Plastic Surgery · 79d

Cleared Oct 15, 2020

General & Plastic Surgery · 84d

Cleared Jun 30, 2020

Litho 150, Cyber Ho 150

General & Plastic Surgery · 29d

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