FDA.reportPublic FDA data

KEELER LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10003910041000391004KEELER LTD.1N2026-01-01CLEWER HILL RD. WINDSOR, BERKSHIRE Windsor and Maidenhead GB SL4 4AA

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
152291428281801K990257KEELER PULSAIR 3000 NON CONTACT TONOMETERHKX1999-03-25
152291843191221K970029KEELER SPECTRA INDIRECT OPHTHALMOSCOPEHLJ1997-04-02
152291515846983K942180KEELER MULTILASE 3000HQF1994-11-22
152291834812679K942104KEELER VANTAGE INDIRECT OPHTHALMOSCOPEHLI1994-08-04
152291474021220K893173VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)HLI1989-06-05
152291216878345K893172VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)HLI1989-06-05
152291981818118K893171VISTA STREAK RETINOSCOPE (AC-POWERED)HKL1989-09-21
152291827969881K893170VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)HJM1989-06-05
152291398959930K870203KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5HKK1987-02-12
152291688900651K854244THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPEHLI1985-11-12
152292065562871K243227B-ScanIYO2025-07-11
152291840495816K181143Keeler TonoCare TonometerHKX2019-02-08
152291050558826K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemGEX2017-02-28
152291840021967K152644KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100HKY2015-12-31
152291928717949K151394Keeler Slit LampHJO2015-09-10
152291770424191K142179D-KAT Z-YPEHKY2014-09-17
152291710023511K140450KEELER KAPTURE SOFTWAREHKI2014-06-17
152292020552367K133234T-TYPE D-KAT, R-TYPE D-KATHKY2014-02-21
152291120038167K131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESHRN2013-12-23
152292009658739K131589KEELER SLIT LAMP H-SERIESHJO2013-06-27
152291121349252K100500PSL CLASSIC SLIT LAMPHJO2010-03-09
152291417501436K093445KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)HKY2010-01-19
152291483431278K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000HKX2010-12-10
152291220727655K062412CRYOMATICHRN2006-11-06
152291052882863K060822VANTAGE INDIRECT OPHTHALMOSCOPEHLI2006-05-23
152291242226736K032087KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004HLJ2003-11-26
152291144591424
152291174043954
152291248403113
152291274388299
152291418725084
152291795612981
152291899571454
152291962311807
152291591546367
152291638332825
152291830212588

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HLI102006-05-23
HKY72015-12-31
HJO62015-09-10
HKX52019-02-08
HRN42013-12-23
HLJ32003-11-26
GEX22017-02-28
HKL21989-09-21
HJM21989-06-05
IYO12025-07-11
HKI12014-06-17
HQF11994-11-22
HKK11987-02-12

PMN#