FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K083377 |
ACCUTOME ULTRASOUND, INC. |
ACCUPEN |
07/27/2009 |
K963079 |
CANON U.S.A., INC. |
CANON TX-10 TONOMETER |
03/03/1997 |
K111710 |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
FULL AUTO TONOMETER MODEL TX-20 |
09/20/2011 |
K023816 |
CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION |
CANON FULL AUTO TONOMETER TX-F |
11/26/2002 |
K190382 |
Company Elamed |
Intraocular Pressure Tonometer EASYTON |
12/06/2019 |
K180820 |
Crystalvue Medical Corporation |
Tono Vue Non-Contact Tonometer |
12/14/2018 |
K181143 |
Keeler Instruments Inc. |
Keeler TonoCare Tonometer |
02/08/2019 |
K990257 |
KEELER INSTRUMENTS, INC. |
KEELER PULSAIR 3000 NON CONTACT TONOMETER |
03/25/1999 |
K093298 |
KEELER INSTRUMENTS, INC. |
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 |
12/10/2010 |
K053444 |
KOWA CO. LTD. |
KOWA KT-800 |
06/09/2006 |
K013805 |
KOWA OPTIMED, INC. |
KOWA AUTOMATED TONOMETER KT-500 |
10/11/2002 |
K010998 |
LANGHAM OPHTHALMIC TECHNOLOGIES |
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 |
06/27/2001 |
K990869 |
LEICA MICROSYSTEMS, INC. |
LEICA AT550 |
06/07/1999 |
K013259 |
LEICA MICROSYSTEMS, INC. O.I.D. |
PORTABLE NON-CONTACT TONOMETER, MODEL PT100 |
02/20/2002 |
K143086 |
LUNEAU SAS |
VX120 Ophthalmic Diagnostic Device |
06/01/2015 |
K162067 |
LUNEAU SAS |
VX130 Ophthalmic Diagnostic Device |
04/24/2017 |
K181260 |
Medimaging Integrated Solution Inc. (MiiS) |
MiiS Horus Scope DPT 100 |
06/21/2019 |
K031733 |
NIDEK, INC. |
NON-CONTACT TONOMETER, MODEL NT-4000 |
12/04/2003 |
K113066 |
OCULUS OPTIKGERATE GMBH |
CORVIS ST |
11/08/2012 |
K002510 |
ODC OPHTHALMIC DEVELOPMENT CO. AG |
SMARTLENS |
10/18/2000 |
K023676 |
OPTILASA S.L. |
APPLANATION TONOMETER |
04/24/2003 |
K032799 |
REICHERT INC. |
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER |
01/20/2004 |
K081756 |
REICHERT INC. |
OCULAR RESPONSE ANALYZER |
08/07/2008 |
K042099 |
RETINAPHARMA TECHNOLOGIES INC. |
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) |
12/10/2004 |
K060780 |
RYAZAN STATE INSTRUMENTS |
TONOMETER DIATON |
04/06/2006 |
K073087 |
TOMEY CORPORATION |
NON-CONTACT TONOMETER, MODEL FT-1000 |
11/18/2008 |
K021937 |
TRUEVISION INSTRUMENTS |
TGDC-01 PRA |
10/11/2002 |
K002395 |
XOMED, INC. |
MODEL 30 CLASSIC PNEUMATONOMETER |
12/11/2000 |