Cleared Traditional

K063352 - ELLEX SLIT LAMP

K063352 is the FDA 510(k) clearance for ELLEX SLIT LAMP by Takagi Seiko Co., Ltd.. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K063352 · Takagi Seiko Co., Ltd. · Ophthalmic device
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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.

View all Takagi Seiko Co., Ltd. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 110d · 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.

Regulatory Peers - HJO Biomicroscope, Slit-lamp, Ac-powered

All 26
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K063352.
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