Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LSFG-NAVI

K-Number: K153239 · 2016-05-12

ApplicantSoftcare Co., Ltd.
Decision Date2016-05-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LSFG-NAVI is a medical device manufactured by Softcare Co., Ltd.. It received FDA 510(k) clearance on 2016-05-12 under approval number K153239. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSFG-NAVI?

LSFG-NAVI is a medical device that received FDA 510(k) clearance on 2016-05-12. It is manufactured by Softcare Co., Ltd.. The 510(k) number is K153239.

When was LSFG-NAVI approved by the FDA?

LSFG-NAVI received FDA 510(k) clearance on 2016-05-12, under approval number K153239.

What company makes LSFG-NAVI?

LSFG-NAVI is manufactured by Softcare Co., Ltd..

What is the FDA product code for LSFG-NAVI?

The FDA product code for LSFG-NAVI is HKI.

Related Devices (Code: HKI)

K161727Eyenez Ophthalmic CameraEyenez, LLC K152729MICROPERIMETER MP-3Nidek Co., Ltd. K152869LipiView II Ocular Surface InterferometerTearscience, Inc. K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical K163021HAAG-STREIT FUNDUS MODULE 300Optomed OY K1830593nethra neoForus Health Pvt.Ltd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑