510(k) Report

FDA applicant

Quanta System Spa

Samarate, IT57 decisions2006–20256 recalls

FDA records 57 decisions for Quanta System Spa (Samarate, IT) from 2006 to 2025: 57 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 43 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 112 predicates, 46 of them its own earlier devices. 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Quanta System Spa’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 22008: 32009: 22010: 22011: 22012: 12013: 42014: 22015: 42016: 42017: 72018: 62019: 32020: 52021: 12022: 22023: 22024: 22025: 2
2007high 7 (2017) · low 1 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2021

2012: 32021: 3
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Quanta System Spa by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Quanta System Spa’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument57decisions

How long do its 510(k) reviews take?

Since 2016, its 34 510(k)s took a median of 43 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 28 of its 34 were faster than that.

Whose devices does it build on?

Its devices cite 112 predicates; 46 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 116 times; 46 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100558Quanta Diode Laser SystemQuanta System Spa · 201014cite it
  • K202503ChromeQuanta System Spa · 20208cite it
  • K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 20077cite it
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 20086cite it
  • K152714Quanta ForteQuanta System Spa · 20155cite it
  • K073549Q-Plus TQuanta System Spa · 20085cite it

What has FDA decided for it lately?

  • K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa · 2025
  • K243588Single Use CO2 Laser Fiber (HAF005001)Quanta System Spa · 2025
  • K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024
  • K242251Litho 60; Litho 100; Litho 150Quanta System Spa · 2024
  • K232236EchoQuanta System Spa · 2023
  • K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa · 2023
  • K220426Fiber Dust PROQuanta System Spa · 2022
  • K211228RossoQuanta System Spa · 2022

All 57 as Quanta System Spa →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K160513Quanta System Sterile Optical Laser Fiber, reusableApr 27, 2021Class II
  • K131473Quanta System Sterile Optical Laser Fiber, single useApr 27, 2021Class II
  • K180158Olympus Sterile Optical Laser Fiber, single use and reusableApr 27, 2021Class II
  • K070805Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG…Nov 7, 2012Class II
  • K051113Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction…Nov 7, 2012Class II
  • K073549Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of…Nov 7, 2012Class II

Other applicant names beginning “Quanta”

FDA records each applicant name separately; these may or may not be the same firm.

Quanta Computer, Inc. 5Quanta Dialysis Technologies, Ltd. 4