Product code HLI— Ophthalmic
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- Classification name
- Ophthalmoscope, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Total cleared
- 87
- First cleared
- Most recent
Market context for product code HLI
FDA has cleared devices under product code HLI between 1977 and 2016, filed by 38 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2007
- 2006
- 2005
- 2004
- 2003
- 2001
- 2000
- 1999
Top applicants under product code HLI
Recent clearances under product code HLI
- K153080 — RTVue XR OCT Avanti with AngioVue Software
- K150722 — EnFocus 2300, EnFocus 4400
- K142953 — OCT-Camera
- K141638 — PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
- K133758 — CENTERVUE MACULAR INTEGRITY ASSESSMENT
- K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES
- K133892 — IVUE 500
- K123316 — HEINE OMEGA 500
- K121739 — IVUE WITH NORMATIVE DATABASE
- K120057 — ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
- K120238 — RTVUE XR OCT
- K111531 — RHA2020
- K103266 — ISTAND
- K110205 — AAIO-7, AAIO WIRLESS
- K101505 — RTVUE MODEL RTVUE 100
- K100861 — R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
- K063378 — CIRRUS HD-OCT, MODEL 4000
- K063343 — BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
- K061674 — RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
- K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE
- K051789 — VISANTE OCT
- K042885 — OCT-OPTHALMOSCOPE
- K042001 — PANORAMIC 200A
- K041290 — RTA MODEL D RETINAL THICKNESS ANALYZER
- K033123 — STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
- K031312 — RTA MODEL D RETINAL THICKNESS ANALYZER
- K030433 — STRATUSOCT WITH RNFL NORMATIVE DATABASE
- K003376 — WELCH ALLYN 11800 OPTHALMOSCOPE
- K994340 — CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
- K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
- K000731 — MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
- K983999 — PANORAMIC200 OPTHALMOSCOPE
- K981640 — S2LO
- K971671 — HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
- K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
- K964137 — RTA RETINAL THICKNESS ANALYZER
- K961171 — HUMPHREY OCT SCANNER
- K951132 — ANGIOSCAN (AS STAND ALONE INSTRUMENT)
- K951210 — WELCH ALLYN VIDEO OPHTHALMOSCOPE
- K951338 — INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
- K950461 — WELCH ALLYN OPHTHALMOSCOPE
- K943955 — RETINA FLOWMETER
- K943956 — RETINA TOMOGRAPH AND FLOWMETER
- K944261 — RETINA ANGIOGRAPH
- K942711 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
- K942712 — NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
- K942713 — NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
- K942714 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
- K942715 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
- K942720 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
- K942104 — KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
- K941705 — NERVE FIBER ANALYZER
- K935988 — R&D BATTERIES # 5615, 5234, 5097
- K930023 — MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
- K923742 — TOPOGRAPHIC SCANNING SYSTEM TOPSS
- K921163 — REGALTECH MAXISCOPE
- K914484 — LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
- K912581 — ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
- K912397 — PROFESSIONAL INDIRECT OPHTHALMOSCOPE
- K913118 — GLAUCOMA-SCOPE
- K912891 — HEIDELBERG RETINA TOMOGRAPH
- K900111 — KEELER KONAN SPECULAR MICROSCOPE SP3300
- K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
- K893172 — VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
- K893173 — VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
- K882517 — RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- K881984 — EOL, MODEL LIO
- K871268 — RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
- K854244 — THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
- K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
- K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
- K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA
- K843596 — NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
- K843597 — NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
- K844971 — MONOCULAR DIRECT OPHTHALMOSCOPE
- K844054 — CANON AUTO KERATOMETER K-1
- K843812 — WOODLYN CLASSIC CATARACT ACUITY TEST
- K843099 — MAMIYA SLIT LAMP P-1
- K843304 — BINOCULAR INDIRECT OPHTHALMOSCOPE
- K841761 — WOODLYN CLASSIC SLIT LAMP HSSL-CL
- K841764 — WOODLYN CLASSIC JAVAL OPHTHALMOMETER
- K841767 — WOODLYN CLASSIC KERATOMETER
- K841763 — WOODLYN SLIT LAMP HSSL-EC
- K822104 — ALCON INDIRECT OPHTHALMOSCOPE
- K791510 — BLUE FIELD ENTOPTOSCOPE BFE100
- K772214 — OPHTHALMOSCOPE, BINOCULAR, INDIRECT
- K770768 — OPHTHALMOSCOPE, MODEL #11100
Data sourced from openFDA. This site is unofficial and independent of the FDA.