510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Pfizer Laser Systems

Irvine, CA, US

Pfizer Laser Systems appears in FDA device records in Irvine, CA. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
32
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 32 510(k) clearances for Pfizer Laser Systems between 1988 and 1993. The busiest year on record is 1991, with 15. The most recent is 1993, with 3.

Clearances by year, as a table
510(k) clearance decisions for Pfizer Laser Systems, by decision year
YearClearances
19882
19892
19908
199115
19922
19933
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K911288ORIONGEXSubstantially Equivalent
K910826ORION YAG LASER SYSTEM OPHTHALMOLOGYGEXSubstantially Equivalent
K910825ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.GEXSubstantially Equivalent
K912067POLARIS, GYNECOLOGY INDICATIONSGEXSubstantially Equivalent
K910152ORIONGEXSubstantially Equivalent
K912813SIRIUSGEXSubstantially Equivalent
K911926POLARIS, OPHTHALMOLOGYGEXSubstantially Equivalent
K912063POLARIS, ORAL INDICATIONGEXSubstantially Equivalent
K911925POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GUGEXSubstantially Equivalent
K910341POLARISGEXSubstantially Equivalent
K905802CENTAURI/PEGASUSGEXSubstantially Equivalent
K904632CENTAURI YAG LASER SYST, GYNECOLOGYGEXSubstantially Equivalent
K904631CENTAURI YAG LASER SYST, NEUROSURGERYGEXSubstantially Equivalent
K905737CENTAURI/PEGASUSGEXSubstantially Equivalent
K905141CENTAURIHQFSubstantially Equivalent
K905072ALTAIRGEXSubstantially Equivalent
K905082PEGASUS WITH ACCESSORIESGEXSubstantially Equivalent
K904629CENTAURI YAG LASER SYST, UROLOGYGEXSubstantially Equivalent
K904628CENTAURI YAG LASER SYST, GASTROENTEROLOGYGEXSubstantially Equivalent
K904627CENTAURI YAG LASER SYST, EAR, NOSE , THROATGEXSubstantially Equivalent
K904630CENTAURI YAG LASER SYST, OPHTHAMOLOGYGEXSubstantially Equivalent
K903027PEGASUS WITH ACCESSORIESGEXSubstantially Equivalent
K902947PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATIONGEXSubstantially Equivalent
K902946PEGASUS W/ACCESSORIES FOR GENERAL SURGERYGEXSubstantially Equivalent
K902534CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASERGEXSubstantially Equivalent
K900253MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USESGEXSubstantially Equivalent
K900144QUARTZ FIBER CATHETERS AND SURGICAL TIPSGEXSubstantially Equivalent
K89604935 WATT SURGICAL CARBON DIOXIDE LASER SYSTEMGEXSubstantially Equivalent
K885060PEGASUSGEXSubstantially Equivalent
K885291MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIESGEXSubstantially Equivalent
K881824LASER MICROMANIPULATORGEXSubstantially Equivalent
K880890THE S.A.F.E. SYSTEMFYDSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain