Schwartz Electro-Optics, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Schwartz Electro-Optics, Inc.” (first 1995, latest 1998), across 1 product code in 1 review panel. Median 510(k) review time under this name: 88 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 | 9 | 9 |
Review panels
Most recent Schwartz Electro-Optics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980710 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM | GEX | 1998-05-22 | 87 |
| K980313 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | GEX | 1998-03-19 | 51 |
| K973867 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM | GEX | 1998-02-10 | 141 |
| K974039 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE | GEX | 1998-01-12 | 88 |
| K973603 | SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM | GEX | 1997-12-19 | 88 |
| K971404 | SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER | GEX | 1997-07-09 | 84 |
| K953585 | SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER | GEX | 1996-02-05 | 188 |
| K954013 | TRILASE 2940 ERBIUM LASER | GEX | 1996-01-31 | 159 |
| K952554 | SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM | GEX | 1995-08-28 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named Schwartz Electro-Optics, 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 Schwartz Electro-Optics, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Schwartz Electro-Optics, Inc.” (first 1995, latest 1998), 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 Schwartz Electro-Optics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schwartz Electro-Optics, Inc. is 88 days.
Which FDA product codes appear under Schwartz Electro-Optics, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9).
Next steps
- See all 9 Schwartz Electro-Optics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Schwartz Electro-Optics, 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.