Quanta System Spa: FDA filings under this applicant name
FDA lists 57 510(k) clearances under the applicant name “Quanta System Spa” (first 2006, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 72 days. Since 2017 the median was 54 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 72 |
| 2013 | 4 | 148 |
| 2014 | 2 | 86 |
| 2015 | 4 | 112 |
| 2016 | 4 | 28 |
| 2017 | 7 | 30 |
| 2018 | 6 | 28 |
| 2019 | 3 | 56 |
| 2020 | 5 | 79 |
| 2021 | 1 | 51 |
| 2022 | 2 | 158 |
| 2023 | 2 | 78 |
| 2024 | 2 | 102 |
| 2025 | 2 | 256 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Quanta System Spa took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 57 | 57 |
Review panels
Most recent Quanta System Spa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240983 | Discovery Pico; Discovery Pico Plus; Discovery Pico Derm | GEX | 2025-06-06 | 422 |
| K243588 | Single Use CO2 Laser Fiber (HAF005001) | GEX | 2025-02-19 | 91 |
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | GEX | 2024-10-10 | 171 |
| K242251 | Litho 60; Litho 100; Litho 150 | GEX | 2024-09-03 | 34 |
| K232236 | Echo | GEX | 2023-10-20 | 85 |
| K223404 | Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V | GEX | 2023-01-20 | 72 |
| K220426 | Fiber Dust PRO | GEX | 2022-03-16 | 30 |
| K211228 | Rosso | GEX | 2022-02-02 | 285 |
| K210142 | Fiber Dust | GEX | 2021-03-11 | 51 |
| K202503 | Chrome | GEX | 2020-11-18 | 79 |
47 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Quanta System Spa.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Quanta Computer, Inc. (5 510(k)s)
- Quanta Dialysis Technologies, Ltd. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quanta System Spa?
FDA lists 57 510(k) clearances under the applicant name “Quanta System Spa” (first 2006, latest 2025), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Quanta System Spa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quanta System Spa is 72 days. Since 2017: 54 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Quanta System Spa?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 57).
Next steps
- See all 57 Quanta System Spa clearances with predicates and recalls
- Run predicate analysis for product code GEX, Quanta System Spa's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.