Cleared Traditional

K063352 - ELLEX SLIT LAMP, MODEL 30XL (FDA 510(k) Clearance)

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

K063352 · Takagi Seiko Co., Ltd. · Ophthalmic device
Mar 2007
Decision
127d
Days
Class 2
Risk

K063352 is an FDA 510(k) clearance for the ELLEX SLIT LAMP, MODEL 30XL. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Takagi Seiko Co., Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on March 13, 2007 after a review of 127 days - within the typical 510(k) review window.

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 K063352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date March 13, 2007
Days to Decision 127 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 156d · This submission: 127d
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.