Cleared Traditional

K153239 - LSFG-NAVI

K153239 is an FDA 510(k) clearance for LSFG-NAVI, manufactured by Softcare Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K153239 · Softcare Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
185d
Days
Class 2
Risk

K153239 is an FDA 510(k) clearance for the LSFG-NAVI. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Softcare Co., Ltd. (Fukutsu, JP). The FDA issued a Cleared decision on May 12, 2016 after a review of 185 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Softcare Co., Ltd. devices

FDA 510(k) Submission Details - K153239

510(k) Number K153239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date May 12, 2016
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Globizz Corporation
Takahiro Haruyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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