Summit Technology, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Summit Technology, Inc.” (first 1990, latest 1998), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 180 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Alcon, based on public ownership records.
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 |
|---|---|---|---|
| EQH | Source, Carrier, Fiberoptic Light | 2 | 2 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HNO | Keratome, Ac-Powered | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
Most recent Summit Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME | HNO | 1998-12-22 | 305 |
| K926470 | LASER AND EMPHASIS SCLEROSTOMY TIP | HQF | 1993-07-22 | 206 |
| K915651 | OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM | GEX | 1992-06-15 | 180 |
| K912522 | OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER | EQH | 1991-07-25 | 64 |
| K904470 | SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE | EQH | 1990-12-24 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Summit Technology, 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.
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.
- Summit Medical, Inc. (14 510(k)s)
- Summit World Trade Corp. (10 510(k)s)
- Summit Industries, Inc. (8 510(k)s)
- Summit Doppler Systems, Inc. (7 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Glove, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
- Summit Access, LLC (1 510(k)s)
- Summit Durable Medical Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit Technology, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Summit Technology, Inc.” (first 1990, latest 1998), across 4 product codes in 3 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 Summit Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit Technology, Inc. is 180 days.
Which FDA product codes appear under Summit Technology, Inc.?
The most frequent FDA product codes under this applicant name are EQH (Source, Carrier, Fiberoptic Light, 2); GEX (Powered Laser Surgical Instrument, 1); HNO (Keratome, Ac-Powered, 1).
Next steps
- See all 5 Summit Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EQH, Summit Technology, 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.