Pfizer Laser Systems: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Pfizer Laser Systems” (first 1988, latest 1993), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 100 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 | 30 | 30 |
| FYD | Apparatus, Exhaust, Surgical | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
Review panels
Most recent Pfizer Laser Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911288 | ORION | GEX | 1993-11-16 | 992 |
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | GEX | 1993-11-16 | 998 |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | GEX | 1993-02-26 | 744 |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | GEX | 1992-06-16 | 403 |
| K910152 | ORION | GEX | 1992-04-15 | 457 |
| K912813 | SIRIUS | GEX | 1991-12-31 | 194 |
| K911926 | POLARIS, OPHTHALMOLOGY | GEX | 1991-11-07 | 195 |
| K912063 | POLARIS, ORAL INDICATION | GEX | 1991-10-16 | 160 |
| K911925 | POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU | GEX | 1991-10-11 | 169 |
| K910341 | POLARIS | GEX | 1991-10-11 | 256 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pfizer Laser Systems.
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.
- Pfizer, Inc. (30 510(k)s)
- Pfizer Medical Systems, Inc. (12 510(k)s)
- Pfizer Hospital Products Group, Inc. (8 510(k)s)
- Pfizer Pharmaceuticals (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pfizer Laser Systems?
FDA lists 32 510(k) clearances under the applicant name “Pfizer Laser Systems” (first 1988, latest 1993), across 3 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 Pfizer Laser Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pfizer Laser Systems is 100 days.
Which FDA product codes appear under Pfizer Laser Systems?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 30); FYD (Apparatus, Exhaust, Surgical, 1); HQF (Laser, Ophthalmic, 1).
Next steps
- See all 32 Pfizer Laser Systems clearances with predicates and recalls
- Run predicate analysis for product code GEX, Pfizer Laser Systems'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.