LSFG-NAVI
Camera, Ophthalmic, Ac-powered
Softcare Co., Ltd
The following data is part of a premarket notification filed by Softcare Co., Ltd with the FDA for Lsfg-navi.
Pre-market Notification Details
| Device ID | K153239 |
| 510k Number | K153239 |
| Device Name: | LSFG-NAVI |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Softcare Co., Ltd 243-5 Yatsunami Fukutsu, JP 811-3201 |
| Contact | Noriyoshi Takahashi |
| Correspondent | Takahiro Haruyama GLOBIZZ CORPORATION 1411 W. 190TH ST. SUITE 200 Gardena, CA 90248 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-05-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04589662680028 | K153239 | 000 |
| 04589662680035 | K153239 | 000 |
Trademark Results [LSFG-NAVI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LSFG-NAVI 79220153 5430656 Live/Registered |
SOFTCARE CO., LTD. 2017-08-21 |
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