Product code HLQ— Ophthalmic

FDA has cleared 29 devices under product code HLQ between 1979 and 2001, filed by 22 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20011 clearance
• 19972 clearances
• 19951 clearance
• 19943 clearances
• 19932 clearances
• 19921 clearance
• 19913 clearances
• 19904 clearances
• 19892 clearances
• 19872 clearances
• 19862 clearances
• 19853 clearances
• 19841 clearance
• 19831 clearance
• 19791 clearance

• Nidek, Inc.3 clearances
• Kera Corp.3 clearances
• Computed Anatomy, Inc.3 clearances
• Canon USA, Inc.2 clearances
• Zeiss Humphrey System1 clearance
• Woodlyn, Inc.1 clearance
• Visioptic, Inc.1 clearance
• Visionary Systems, Inc.1 clearance
• Reichert Ophthalmic Instruments, Div. Leica, Inc.1 clearance
• Par Microsystems Corp.1 clearance

• K003299 — OPD-SCAN, MODELS ARK-10000 AND ARK-9000Nidek Co., Ltd.·2001-03-09
• K973756 — EYE SYS VISTAEyesys Technologies, Inc.·1997-11-13
• K964290 — EYECHEKReichert Ophthalmic Instruments, Div. Leica, Inc.·1997-01-09
• K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.·1995-01-31
• K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2Computed Anatomy, Inc.·1994-12-07
• K944616 — KERATRON CORNEAL TOPOGRAPHERAlliance Medical Marketinig·1994-11-22
• K940647 — ORBSCAN(TM) KERATOMETEROrbtek, Inc.·1994-07-06
• K933556 — EH-270 CORNEAL TOPOGRAPHERVisioptic, Inc.·1993-11-02
• K923435 — CORNEAL TOPOGRAPHY SYSTEMPar Microsystems Corp.·1993-02-16
• K922253 — KERATOREF L60Luneau Ophtalmologie SA·1992-06-19
• K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER)Visionary Systems, Inc.·1991-12-30
• K913022 — CCI VIDEOKERATOSCOPE/COMPARATORCci·1991-10-09
• K912130 — TBD KERATOSCOPEAlcon Laboratories·1991-08-09
• K895741 — CLAS PHOTOKERATOSCOPEKera-Metrics Corp.·1990-07-11
• K902012 — VKS-1 VIDEO KERATOSCOPEComputed Anatomy, Inc.·1990-06-22
• K901009 — MODEL 2000 INTRAOPERATIVE CORNEASCOPEKera Corp.·1990-05-30
• K901363 — TOPOGRAPHIC MODELING SYSTEMComputed Anatomy, Inc.·1990-05-25
• K895475 — CANON AUTO REF-KERATOMETER RK-2Canon USA, Inc.·1989-10-31
• K890687 — ECT-100 ELECTRONIC CORNEAL TOPOGRAPHEROptimed, Inc.·1989-09-05
• K871936 — CANON SURGICAL AUTO KERATOMETER SK-1Canon USA, Inc.·1987-06-19
• K871479 — VIDEOSCAN (TM)Kera Corp.·1987-05-22
• K862137 — NIDEK KM-1000 SURGICAL KERATOMETERNidek, Inc.·1986-07-23
• K861063 — NIDEK KM-800 AUTO KERATOMETERNidek, Inc.·1986-04-04
• K853668 — ORC ORACLEOptical Radiation Corp.·1985-10-15
• K853723 — ZEISS OPERATING KERATOMETERCarl Zeiss, Inc.·1985-10-15
• K850665 — CORNEASCOPE MODEL 1200Kera Corp.·1985-03-20
• K841765 — WOODLYN STANDARD SLIT LAMP HSSL-STWoodlyn, Inc.·1984-08-07
• K831084 — SUN PHOTO-KERATOSCOPENidek, Inc.·1983-06-30
• K781994 — AUTOKERATOMETER, INSTRUMENTZeiss Humphrey System·1979-02-12