HLJ — Ophthalmoscope, Battery-Powered Class II
FDA product code HLJ covers "Ophthalmoscope, Battery-Powered", a Class II medical device regulated under 21 CFR 886.1570. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLJ
- Device Class
- Class II
- Regulation Number
- 886.1570
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K142486 | heine optotechnik gmbh and co. kg | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | May 18, 2015 |
| K142837 | heine optotechnik gmbh and co. kg | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | January 29, 2015 |
| K131959 | heine optotechnik gmbh and co. kg | HEINE MINI 3000(R) OPHTHALMOSCOPE | March 7, 2014 |
| K131961 | heine optotechnik gmbh and co. kg | HEINE BETA 200(R) OPHTHALMOSCOPE | December 4, 2013 |
| K131719 | medical devices (pvt) | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | October 30, 2013 |
| K123587 | heine optotechnik gmbh and co. kg | HEINE MINI 3000 LED OPHTHALMOSCOPE | March 22, 2013 |
| K093495 | american diagnostic | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | November 19, 2010 |
| K070270 | kirchner and wilhelm gmbh + co.kg | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | November 5, 2007 |
| K052599 | suzhou 66 vision tech co | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 | November 7, 2006 |
| K061278 | ophthalmos | OPTYSE OPHTHALMOSCOPE | May 16, 2006 |
| K053425 | precision optics | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | January 9, 2006 |
| K032087 | keeler instruments | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | November 26, 2003 |
| K002044 | magna fortis corporation | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | September 12, 2000 |
| K962767 | alexander mfg | MS401097-17,MS722-K,MS720,MS721,MS722 | July 3, 1997 |
| K970029 | keeler instruments | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | April 2, 1997 |
| K950914 | rudolf riester gmbh and co. kg | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAEST | July 24, 1995 |
| K950797 | neitz instruments company | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | March 28, 1995 |
| K950796 | neitz instruments company | HALOGEN DIAGNOSTIC SET BX A - 12345 | March 22, 1995 |
| K945640 | rudolf riester gmbh and co. kg | RI-SCOPE S OTOSCOPE | January 17, 1995 |
| K944402 | lacrimedics | FOCOMETER | November 22, 1994 |