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FDA 510(k) Applications Submitted by PAUL H HARDIMAN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K020021
01/03/2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
LASERSCOPE
K990903
03/18/1999
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
LASERSCOPE
K061646
06/12/2006
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
LASERSCOPE
K062719
09/12/2006
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE
K003147
10/10/2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
LASERSCOPE
K024206
12/20/2002
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE
K034011
12/24/2003
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE
K010284
01/31/2001
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
LASERSCOPE
K990718
03/04/1999
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
LASERSCOPE
K010834
03/20/2001
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
LASERSCOPE
K121475
05/18/2012
TXCELL SCANNING LASER DELIVERY SYSTEM
IRIDEX CORP.
K143154
11/03/2014
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
IRIDEX CORPORATION
K984110
11/17/1998
LASERSCOPE COOLSPOT
LASERSCOPE
K984424
12/11/1998
AURA DYE LASER SYSTEM (ADLS)
LASERSCOPE
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