Cleared Traditional

K033190 - VISION-TECH YZ SLIT LAMP

K033190 is an FDA 510(k) clearance for VISION-TECH YZ SLIT LAMP, manufactured by Suzhou 66 Vision-Tech Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K033190 · Suzhou 66 Vision-Tech Co., Ltd. · Ophthalmic device
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Dec 2003
Decision
64d
Days
Class 2
Risk

K033190 is an FDA 510(k) clearance for the VISION-TECH YZ SLIT LAMP, MODEL 66. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Suzhou 66 Vision-Tech Co., Ltd. (Plano, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 64 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.

View all Suzhou 66 Vision-Tech Co., Ltd. devices

FDA 510(k) Submission Details - K033190

510(k) Number K033190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2003
Decision Date December 04, 2003
Days to Decision 64 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
46d faster than avg
Panel avg: 110d · This submission: 64d
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 39
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