Cleared Traditional

K063352 - ELLEX SLIT LAMP, MODEL 30XL

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

K063352 · Takagi Seiko Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K063352

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.

HJO Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K063352.
SLIT LAMP SL-2G
K110489 · Topcon Medical Systems, Inc. · May 2011
IOLMASTER 500
K101182 · Carl Zeiss Meditec, AG · Nov 2010
PSL CLASSIC SLIT LAMP
K100500 · Keeler Instruments, Inc. · Mar 2010
KOWA SL-15
K063640 · Kowa Co. , Ltd. · Dec 2006
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K043503 · Visx, Incorporated · Apr 2005
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001