4Sight
ACCUTOME, INC.
ACCUTOME, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2521877 | 2521877 | ACCUTOME, INC. | 1 | Y | 2026-01-01 | 3222 Phoenixville Pike Malvern PA US 19355 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 38270 | 1411415494 | K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | HKX | 1999-03-25 |
| 38270 | 1594660031 | K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | HLJ | 1997-04-02 |
| 38270 | 1392588808 | K960765 | MENTOR ADVENT A/B SYSTEM | IYO | 1996-08-08 |
| 38270 | 1065256252 | K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE | HLI | 1994-08-04 |
| 38270 | 1747828600 | K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) | HLI | 1989-06-05 |
| 38270 | 1205696419 | K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | HLI | 1989-06-05 |
| 38270 | 1437566106 | K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | HKL | 1989-09-21 |
| 38270 | 1263123801 | K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | HJM | 1989-06-05 |
| 38270 | 1864785261 | K870203 | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | HKK | 1987-02-12 |
| 38270 | 1281293700 | K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE | HLI | 1985-11-12 |
| 38270 | 1063647258 | K181143 | Keeler TonoCare Tonometer | HKX | 2019-02-08 |
| 38270 | 1707409258 | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System | GEX | 2017-02-28 |
| 38270 | 1813809684 | K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | HKY | 2015-12-31 |
| 38270 | 2002903803 | K152573 | 4Sight | IYO | 2015-11-25 |
| 38270 | 1636640215 | K142179 | D-KAT Z-YPE | HKY | 2014-09-17 |
| 38270 | 1173058477 | K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | HJO | 2014-07-11 |
| 38270 | 1341867742 | K140450 | KEELER KAPTURE SOFTWARE | HKI | 2014-06-17 |
| 38270 | 1557981649 | K133234 | T-TYPE D-KAT, R-TYPE D-KAT | HKY | 2014-02-21 |
| 38270 | 1265229987 | K132549 | ACCUTIP COVER | HKY | 2014-04-23 |
| 38270 | 1372520192 | K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | HRN | 2013-12-23 |
| 38270 | 1246353679 | K131589 | KEELER SLIT LAMP H-SERIES | HJO | 2013-06-27 |
| 38270 | 1643147530 | K123349 | A-SCAN PLUS CONNECT | IYO | 2013-01-29 |
| 38270 | 1806067219 | K103471 | UBM PLUS | IYN | 2011-03-14 |
| 38270 | 1744402350 | K100500 | PSL CLASSIC SLIT LAMP | HJO | 2010-03-09 |
| 38270 | 1033752656 | K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | HKY | 2010-01-19 |
| 38270 | 1106712229 | K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | HKX | 2010-12-10 |
| 38270 | 1590001982 | K083377 | ACCUPEN | HKX | 2009-07-27 |
| 38270 | 1863923663 | K070943 | B-SCAN PLUS | IYO | 2007-04-19 |
| 38270 | 1229198728 | K062412 | CRYOMATIC | HRN | 2006-11-06 |
| 38270 | 1093340767 | K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | HLI | 2006-05-23 |
| 38270 | 1100866909 | K053638 | MANI NEEDLE & SUTURE PACK (SILK) | GAP | 2006-05-19 |
| 38270 | 1394039545 | K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | GAR | 2006-05-19 |
| 38270 | 1163064161 | K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) | GAM | 2006-03-14 |
| 38270 | 2068062454 | K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | IYO | 2005-03-28 |
| 38270 | 1001190609 | K050150 | MANI NEEDLE & SUTURE PACK | GAT | 2005-12-05 |
| 38270 | 1428761581 | K042752 | ACCUPACH V | IYO | 2004-11-10 |
| 38270 | 2042778355 | K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 | IYO | 2003-10-10 |
| 38270 | 1888074750 | K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | HLJ | 2003-11-26 |
| 38270 | 1256861203 | K023525 | RETISCAN, RETIPORT | GWE | 2004-03-26 |
| 38270 | 1123521042 | ||||
| 38270 | 1002732689 | ||||
| 38270 | 1012527191 | ||||
| 38270 | 1027683615 | ||||
| 38270 | 1032964555 | ||||
| 38270 | 1117150160 | ||||
| 38270 | 1132379772 | ||||
| 38270 | 1147430362 | ||||
| 38270 | 1193317661 | ||||
| 38270 | 1312916867 | ||||
| 38270 | 1327411641 | ||||
| 38270 | 1408398176 | ||||
| 38270 | 1447461337 | ||||
| 38270 | 1472114921 | ||||
| 38270 | 1496952391 | ||||
| 38270 | 1511282425 | ||||
| 38270 | 1651495341 | ||||
| 38270 | 1661059157 | ||||
| 38270 | 1663386996 | ||||
| 38270 | 1744354546 | ||||
| 38270 | 1753470081 | ||||
| 38270 | 1845880293 | ||||
| 38270 | 1860536666 | ||||
| 38270 | 1883535925 | ||||
| 38270 | 1949991600 | ||||
| 38270 | 1957340156 | ||||
| 38270 | 2005429526 | ||||
| 38270 | 2021180681 | ||||
| 38270 | 2053004053 | ||||
| 38270 | 2053996954 | ||||
| 38270 | 2070457882 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYO | 7 | 2015-11-25 |
| HKY | 5 | 2015-12-31 |
| HLI | 5 | 2006-05-23 |
| HKX | 4 | 2019-02-08 |
| HJO | 3 | 2014-07-11 |
| HRN | 2 | 2013-12-23 |
| HLJ | 2 | 2003-11-26 |
| GEX | 1 | 2017-02-28 |
| HKI | 1 | 2014-06-17 |
| IYN | 1 | 2011-03-14 |
| GAP | 1 | 2006-05-19 |
| GAR | 1 | 2006-05-19 |
| GAM | 1 | 2006-03-14 |
| GAT | 1 | 2005-12-05 |
| GWE | 1 | 2004-03-26 |
| HKL | 1 | 1989-09-21 |
| HJM | 1 | 1989-06-05 |
| HKK | 1 | 1987-02-12 |
PMN#
ACCUTIP COVER
ACCUTOME, INC.
A-SCAN PLUS CONNECT
ACCUTOME, INC.
UBM PLUS
ACCUTOME, INC.
ACCUPEN
ACCUTOME ULTRASOUND, INC.
B-SCAN PLUS
ACCUTOME ULTRASOUND, INC.
PACHPEN PACHYMETER, MODEL 24-5100
ACCUTOME, INC.
ACCUPACH V
ACCUTOME ULTRASOUND, INC.
ACCUSONIC A-SCAN MODEL, 24-4000
ACCUTOME, INC.
KREMER BLADE GAUGE
ACCUTOME, INC.
KREMER CORNEOMETER ULTRASONIC PACHOMETER
ACCUTOME, INC.
GUDID#
AccuTip Cover - Individually wrapped
2016-09-13
AccuTip Cover - Individually wrapped
2016-09-13
AccuTip Cover - Sleeved
2016-09-13
AccuTip Cover - Bulk, non-sleeved
2016-09-13
Accupen - 24-3000
2016-09-13
Pachpen - 24-5100
2016-09-13
A-scan Plus Connect - 24-4400
2016-09-13
B-scan Plus - 24-6100
2016-09-13
Accupach VI - 24-6200
2016-09-13
B-scan Pro - 24-6400
2016-09-13
4Sight - 24-8000
2016-09-13
4Sight: Software Package - 2.06.02-U
2016-09-21
B-scan Plus: Software Package - 4.07.02-U
2016-09-21
A-scan Plus Connect: Software Package - 7.00.02-U
2016-09-21
B-scan Plus Software Package: Veterinary Version - 1.03.03-U
2016-09-23
B-scan Pro Software Package: Veterinary Version - 4.07.02-U
2016-09-23
B-scan Plus- VET - Veterinary
2016-10-14
B-scan Pro- VET - Veterinary
2016-10-14
Pachpen- VET - Veterinary
2016-10-14
UBM Plus - 24-6300
2016-09-13
UBM Plus: Software Package - 4.07.02-U
2016-09-21
UBM Software Package: Veterinary Version - 4.07.02-U
2016-09-23
UBM- VET - Veterinary
2016-10-14
B-scan Pro: Software Package - 1.03.03-U
2016-09-21
A-scan Plus Connect- VET - Veterinary
2016-10-14