Cleared Traditional

K063416 - LUXVISION SLIT LAMP

K063416 is an FDA 510(k) clearance for LUXVISION SLIT LAMP, manufactured by Us Ophthalmic, LLC. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K063416 · Us Ophthalmic, LLC · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
24d
Days
Class 2
Risk

K063416 is an FDA 510(k) clearance for the LUXVISION SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Us Ophthalmic, LLC (Miami, US). The FDA issued a Cleared decision on December 7, 2006 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063416

510(k) Number K063416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date December 07, 2006
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
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 105
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K063416.
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K060869 · Rightmedical Products, LLC · May 2006
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K043503 · Visx, Incorporated · Apr 2005
K063416 · LUXVISION SLIT LAMP
Download PDF FDA Summary Us Ophthalmic, LLC