Spectragenics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spectragenics, Inc.” (first 2003, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 91 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 5 | 5 |
Review panels
Most recent Spectragenics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090820 | TRIA HAIR REMOVAL LASER SYSTEM | GEX | 2009-12-23 | 272 |
| K053527 | SPECTRA HAIR REMOVAL LASER | GEX | 2008-02-01 | 774 |
| K060567 | SPECTRAGENICS ATS-1 | GEX | 2006-04-28 | 56 |
| K052848 | SPECTRA HAIR REMOVAL LASER | GEX | 2005-12-27 | 81 |
| K032846 | SPECTRA PULSED DIODE LASER, MODEL DR-1 | GEX | 2003-12-11 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Spectragenics, 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 Spectragenics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Spectragenics, Inc.” (first 2003, latest 2009), 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 Spectragenics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectragenics, Inc. is 91 days.
Which FDA product codes appear under Spectragenics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 5).
Next steps
- See all 5 Spectragenics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Spectragenics, 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 (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.