510(k) K052599
- Device
- 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
- Applicant
- SUZHOU 66 VISION TECH CO., LTD.
- 510(k) number
- K052599
- Product code
- HLJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-11-07
- Date received
- 2005-09-21
- Regulation
- 886.1570
- Classification name
- Ophthalmoscope, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GONG BO
- Address
- 600/8/503 Liuzhou Rd. Shanghai CN 200233 200233
FDA Registration Numbers#
- 1000391004
- 3013557562
- 1416980
- 3030447506
- 3033536319
- 3038356864
- 2521877
- 2132111
- 3004095901
- 3005771344
- 3013298431
- 3034205503
- 1316463
- 3015286905
- 8043512
- 3014579161
- 3009275598
- 3011898560
- 3005536872
- 3007817024
- 1054713
- 3011499367
- 3013846070
- 3006252153
- 1937310
- 9615030
- 3003431869
- 8010482
- 9614084
- 3008338766
- 8010427
- 3005785090
- 3000268902
- 3006550126
- 1314417
- 3012421607
- 3003882387
- 3006087789
- 3004598675
- 3012104670
- 3017805218
- 3012494290
- 3017303999
- 2434008
- 1720747
- 3001124136
- 2031962
- 3042888274
- 1000379039
- 3010675798
- 3026875454
- 3015997711
- 3015512299
- 3013436538
- 3009255580
- 9613073
- 1528142
- 3003553186
- 3027556548
- 3013901429
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HLJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | 2015-05-18 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015-01-29 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2014-03-07 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-12-04 |
| K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | 2013-10-30 |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-03-22 |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | American Diagnostic Corp. | 2010-11-19 |
| K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | 2007-11-05 |
| K061278 | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | 2006-05-16 |
| K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | 2006-01-09 |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | 2003-11-26 |
| K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | 2000-09-12 |
| K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 | Alexander Mfg. Co. | 1997-07-03 |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1997-04-02 |
| 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 | Rudolf Riester GmbH & Co. KG | 1995-07-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases