Fibra Sonics, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Fibra Sonics, Inc.” (first 1980, latest 1999), across 6 product codes in 5 review panels. Median 510(k) review time under this name: 86 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | 3 | 3 |
| FEO | Lithotriptor, Ultrasonic | 2 | 2 |
| LFL | Instrument, Ultrasonic Surgical | 2 | 2 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Ophthalmic (4)
- Gastroenterology and Urology (2)
- General and Plastic Surgery (2)
- Dental (1)
- Physical Medicine (1)
Most recent Fibra Sonics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | FEO | 1999-11-22 | 73 |
| K984199 | EXONIX | IMI | 1999-02-17 | 85 |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | HQC | 1999-02-16 | 90 |
| K983199 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL | LFL | 1998-12-14 | 91 |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | LFL | 1998-09-22 | 194 |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | FEO | 1984-12-11 | 207 |
| K834453 | PHACO FRAGMENTOR GT-1 | HQC | 1984-03-16 | 88 |
| K813389 | ULTRASONIC FRAGMENTOR | HQE | 1982-02-04 | 63 |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | ELC | 1981-12-14 | 56 |
| K802381 | LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. | HQC | 1980-12-17 | 79 |
Recalls
openFDA lists no recalls under a recalling firm named Fibra Sonics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fibra Sonics, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Fibra Sonics, Inc.” (first 1980, latest 1999), across 6 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fibra Sonics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fibra Sonics, Inc. is 86 days.
Which FDA product codes appear under Fibra Sonics, Inc.?
The most frequent FDA product codes under this applicant name are HQC (Unit, Phacofragmentation, 3); FEO (Lithotriptor, Ultrasonic, 2); LFL (Instrument, Ultrasonic Surgical, 2).
Next steps
- See all 10 Fibra Sonics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQC, Fibra Sonics, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.