Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pfizer Laser Systems — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
457 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910826 | ORION YAG LASER SYSTEM OPHTHALMOLOGY | Pfizer Laser Systems | 1993-11-16 | 998 | 0 |
| K911288 | ORION | Pfizer Laser Systems | 1993-11-16 | 992 | 0 |
| K910825 | ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC. | Pfizer Laser Systems | 1993-02-26 | 744 | 0 |
| K912067 | POLARIS, GYNECOLOGY INDICATIONS | Pfizer Laser Systems | 1992-06-16 | 403 | 0 |
| K910152 | ORION | Pfizer Laser Systems | 1992-04-15 | 457 | 0 |
| K912813 | SIRIUS | Pfizer Laser Systems | 1991-12-31 | 194 | 0 |
| K911926 | POLARIS, OPHTHALMOLOGY | Pfizer Laser Systems | 1991-11-07 | 195 | 0 |
| K912063 | POLARIS, ORAL INDICATION | Pfizer Laser Systems | 1991-10-16 | 160 | 0 |
| K911925 | POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU | Pfizer Laser Systems | 1991-10-11 | 169 | 0 |
| K910341 | POLARIS | Pfizer Laser Systems | 1991-10-11 | 256 | 0 |
| K905802 | CENTAURI/PEGASUS | Pfizer Laser Systems | 1991-07-19 | 203 | 0 |
| K904632 | CENTAURI YAG LASER SYST, GYNECOLOGY | Pfizer Laser Systems | 1991-07-11 | 275 | 0 |
| K904631 | CENTAURI YAG LASER SYST, NEUROSURGERY | Pfizer Laser Systems | 1991-06-18 | 252 | 0 |
| K905737 | CENTAURI/PEGASUS | Pfizer Laser Systems | 1991-06-17 | 175 | 0 |
| K905141 | CENTAURI | Pfizer Laser Systems | 1991-02-11 | 88 | 0 |
| K905072 | ALTAIR | Pfizer Laser Systems | 1991-02-07 | 90 | 0 |
| K905082 | PEGASUS WITH ACCESSORIES | Pfizer Laser Systems | 1991-01-31 | 79 | 0 |
| K904627 | CENTAURI YAG LASER SYST, EAR, NOSE , THROAT | Pfizer Laser Systems | 1991-01-07 | 90 | 0 |
| K904629 | CENTAURI YAG LASER SYST, UROLOGY | Pfizer Laser Systems | 1991-01-07 | 90 | 0 |
| K904628 | CENTAURI YAG LASER SYST, GASTROENTEROLOGY | Pfizer Laser Systems | 1991-01-07 | 90 | 0 |
| K904630 | CENTAURI YAG LASER SYST, OPHTHAMOLOGY | Pfizer Laser Systems | 1990-12-17 | 69 | 0 |
| K902947 | PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION | Pfizer Laser Systems | 1990-10-02 | 89 | 0 |
| K903027 | PEGASUS WITH ACCESSORIES | Pfizer Laser Systems | 1990-10-02 | 84 | 0 |
| K902946 | PEGASUS W/ACCESSORIES FOR GENERAL SURGERY | Pfizer Laser Systems | 1990-10-02 | 89 | 0 |
| K902534 | CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER | Pfizer Laser Systems | 1990-09-25 | 109 | 0 |
| K900253 | MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES | Pfizer Laser Systems | 1990-04-05 | 78 | 0 |
| K900144 | QUARTZ FIBER CATHETERS AND SURGICAL TIPS | Pfizer Laser Systems | 1990-02-09 | 29 | 0 |
| K896049 | 35 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM | Pfizer Laser Systems | 1990-01-11 | 85 | 0 |
| K885060 | PEGASUS | Pfizer Laser Systems | 1989-06-02 | 177 | 0 |
| K885291 | MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES | Pfizer Laser Systems | 1989-02-03 | 38 | 0 |
| K881824 | LASER MICROMANIPULATOR | Pfizer Laser Systems | 1988-05-24 | 25 | 0 |
| K880890 | THE S.A.F.E. SYSTEM | Pfizer Laser Systems | 1988-05-11 | 70 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda