FDA Device Registration & Listing · GAMAGORI, AICHI, JP · Registration 8030392
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | Ophthalmic | Class 1 | 886.1700 | 2014-09-04 |
| LXS | Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla | Ophthalmic | Class 2 | 886.4392 | 2007-10-22 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2014-08-17 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2014-08-17 |
| HLQ | Keratoscope, Ac-Powered | Ophthalmic | Class 1 | 886.1350 | 1983-07-14 |
| NQE | Microscope, Specular | Ophthalmic | Class 2 | 886.1850 | 2013-12-19 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | Class 2 | 886.1120 | 2019-04-03 |
| HPT | Perimeter, Automatic, Ac-Powered | Ophthalmic | Class 1 | 886.1605 | 2019-04-03 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2011-02-27 |
| HQB | Photocoagulator And Accessories | Ophthalmic | Class 2 | 886.4690 | 2011-02-27 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | Class 2 | 886.1850 | 2014-06-13 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | Class 2 | 892.1560 | 2014-06-13 |
| HKX | Tonometer, Ac-Powered | Ophthalmic | Class 2 | 886.1930 | 2007-10-22 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2020-12-07 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Ophthalmic | Class 2 | 886.1850 | 2020-12-07 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2020-12-07 |
| HPT | Perimeter, Automatic, Ac-Powered | Ophthalmic | Class 1 | 886.1605 | 2013-07-03 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | Class 2 | 886.1120 | 2013-07-03 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2016-05-05 |
| NQE | Microscope, Specular | Ophthalmic | Class 2 | 886.1850 | 2016-03-22 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | Ophthalmic | Class 1 | 886.1425 | 2006-04-06 |
| HPT | Perimeter, Automatic, Ac-Powered | Ophthalmic | Class 1 | 886.1605 | 2007-04-10 |
| LZS | Excimer Laser System | Unknown | Class 3 | N/A | 2007-02-23 |
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | Ophthalmic | Class 1 | 886.1770 | 2002-08-20 |
| NFG | Device, Communications, Images, Ophthalmic | Radiology | Class 1 | 892.2020 | 2012-05-14 |
| NFF | Device, Storage, Images, Ophthalmic | Radiology | Class 1 | 892.2010 | 2012-05-14 |
| HKI | Camera, Ophthalmic, Ac-Powered | Ophthalmic | Class 2 | 886.1120 | 2012-05-14 |
| NFF | Device, Storage, Images, Ophthalmic | Radiology | Class 1 | 892.2010 | 2005-01-27 |
| HQF | Laser, Ophthalmic | Ophthalmic | Class 2 | 886.4390 | 2011-07-29 |
| HQB | Photocoagulator And Accessories | Ophthalmic | Class 2 | 886.4690 | 2011-07-29 |
| HOX | Chart, Visual Acuity | Ophthalmic | Class 1 | 886.1150 | 2002-08-20 |
| NFG | Device, Communications, Images, Ophthalmic | Radiology | Class 1 | 892.2020 | 2013-08-23 |
| NQE | Microscope, Specular | Ophthalmic | Class 2 | 886.1850 | 2018-03-16 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2936921 | NIDEK INCORPORATED | The Colony, TX, US |
| 3002807715 | NIDEK CO., LTD. HAMACHO PLANT | GAMAGORI, AICHI, JP |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834060 | F. & F. Koenigkramer | RELIANCE OPHTHALMIC SLIT LAMP R-083 | 1984-02-04 |
| K083258 | Dornier Medtech America, Inc. | MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE | 2009-01-30 |
| K201111 | Candela Corporation | GentleMax Pro Plus | 2020-05-26 |
| K202758 | Shangdong Huamei Technology Co., Ltd. | Nd: YAG Laser Therapy Systems HM-YL900 | 2020-11-16 |
| K904068 | Luxar Corp. | LUXAR MODEL LX-20 CO2 LASER | 1991-04-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0005-2014 | PhotoMedex, Inc. | 2 | The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***.
The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081.
Indicated for the incision, excision, coagulations, and vaporization of soft tissue. |
| Z-0025-2018 | Medtronic Navigation, Inc. | 2 | VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;
Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip |
| Z-0028-2007 | Lumenis Inc. | 2 | Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue.
Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA |
| Z-0009-2018 | Optovue, Inc. | 2 | iFusion, Device Listing Number D203271.
Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and
documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND
iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior
and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of
retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. |
| Z-0581-2026 | Alcon Research LLC | 2 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:
25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093;
25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095;
27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096;
23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413;
25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415;
27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417;
TOTAL PLUS,23G,10K VALVE STD/ 8065752435;
TOTAL PLUS,23GA,10K VALVE WD/ 8065752436;
TOTAL PLUS,25+,10K VALVE STD/ 8065752437;
TOTAL PLUS,25+,10K VALVE WD/ 8065752438;
TOTAL PLUS,27+,10K VALVE STD/ 8065752439;
23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448;
23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449;
25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450;
25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451;
27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452;
25+TTLPL VPK 20000CPM BEV VAL/ 8065753106;
27+TTLPL VPK 20000CPM BEV VL/ 8065753109;
HYPERVIT 25+BEV 20000 CPM/ 8065830026;
HYPERVIT 27+BEV 20000 CPM/ 8065830027;
25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077;
25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15;
VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25;
VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27;
23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09;
AUS-25GA VIT RET BRISBANE WATERS/ 12641-13;
AUS-25GA VIT RET BRISBANE WATERS/ 12641-14;
AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16;
23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08;
25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10;
23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13;
25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15;
VITRECTOMY 25G V A HOSPITAL/ 14129-10;
J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12;
CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09;
CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09;
CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10;
CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06;
CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07;
CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08;
CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16;
CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07;
CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15;
CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10;
CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11;
CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09;
CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11;
CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06;
CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07;
CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08;
CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09;
CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07;
CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08;
CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06;
CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07;
CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09;
CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08;
25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13;
CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14;
CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07;
CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07;
CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13;
CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06;
CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05;
CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05;
23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05;
23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06;
27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02;
27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03;
25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05;
25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06;
CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04;
CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05;
CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2032833 | NEUROPTICS, INC. | Irvine, CA, US |
| 2936921 | NIDEK INCORPORATED | The Colony, TX, US |
| 3008058195 | METROVISION SAS | Perenchies Nord, FR |
| 3026045952 | SOLVEMED INC. | Lewes, DE, US |
| 3000308604 | Fielmann Group AG | Hamburg, DE |
8030392 when referencing this establishment in official correspondence.