Cleared Traditional

K091039 - KOWA, FM-600, MODEL LSS50 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091039 · Kowa Co. , Ltd. · Ophthalmic device
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Aug 2009
Decision
116d
Days
Class 2
Risk

K091039 is an FDA 510(k) clearance for the KOWA, FM-600, MODEL LSS50. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Kowa Co. , Ltd. (Chuo-Ku, Tokyo, JP). The FDA issued a Cleared decision on August 7, 2009 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Kowa Co. , Ltd. devices

Submission Details

510(k) Number K091039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date August 07, 2009
Days to Decision 116 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 110d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MYC Ophthalmoscope, Laser, Scanning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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.