Cleared Traditional

K152535 - Z5 Slit lamp microscope, Z2 Slit lamp microscope (FDA 510(k) Clearance)

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

K152535 · Takagi Seiko Co., Ltd. · Ophthalmic device
May 2016
Decision
265d
Days
Class 2
Risk

K152535 is an FDA 510(k) clearance for the Z5 Slit lamp microscope, Z2 Slit lamp microscope. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Takagi Seiko Co., Ltd. (Nakano, JP). The FDA issued a Cleared decision on May 26, 2016 after a review of 265 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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.

Submission Details

510(k) Number K152535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2015
Decision Date May 26, 2016
Days to Decision 265 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 156d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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.