Product code HLJ— Ophthalmic
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
- Classification name
- Ophthalmoscope, Battery-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code HLJ
FDA has cleared devices under product code HLJ between 1976 and 2015, filed by 26 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- 2015
- 2014
- 2013
- 2010
- 2007
- 2006
- 2003
- 2000
- 1997
- 1995
- 1994
- 1993
- 1992
- 1989
- 1987
Top applicants under product code HLJ
Recent clearances under product code HLJ
- K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
- K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2
- K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE
- K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE
- K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
- K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE
- K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
- K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
- K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
- K061278 — OPTYSE OPHTHALMOSCOPE
- K053425 — PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
- K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
- K002044 — MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
- K962767 — MS401097-17,MS722-K,MS720,MS721,MS722
- K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
- K950914 — RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
- K950797 — HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
- K950796 — HALOGEN DIAGNOSTIC SET BX A - 12345
- K945640 — RI-SCOPE S OTOSCOPE
- K944402 — FOCOMETER
- K942717 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
- K942719 — NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
- K942721 — NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
- K942034 — R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
- K936018 — REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
- K936104 — R & D BATTERIES
- K925755 — DE LUXE
- K925756 — UNI II
- K932504 — RI-FORMER
- K925757 — OPHTHALMOSCOPE
- K923543 — MIS
- K922910 — MEDICAL BATTERY PACKS
- K920272 — ORIEL
- K896072 — D.L. SCOPE OPHTHALMOSCOPE
- K873987 — IRAS GLARE TESTER
- K871735 — VOROSCOPE(TM)
- K853891 — INDIRECT OPHTHALMOSCOPE
- K852953 — #SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
- K852334 — MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
- K843897 — POCKET OPHTHALMOSCOPE GH
- K842567 — PORTABLE ACUIOMETER
- K841292 — SPECTACLE INDIRECT OPHTHALMOSCOPE
- K832437 — MEDIC LUX DIAGNOSTIC SETS
- K830215 — DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
- K780215 — EYESCOPE
- K760770 — SOLA COMMIDO LOUPE
- K760771 — SOLA SCHULTZE-CROCK OPTHALMOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.