Cleared Traditional

K100439 - MEDIWORKS SLIT LAMP

K100439 is an FDA 510(k) clearance for MEDIWORKS SLIT LAMP, manufactured by Shanghai Mediworks Precision Instruments Co. , Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K100439 · Shanghai Mediworks Precision Instruments Co. , Ltd. · Ophthalmic device
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Jul 2010
Decision
149d
Days
Class 2
Risk

K100439 is an FDA 510(k) clearance for the MEDIWORKS SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Shanghai Mediworks Precision Instruments Co. , Ltd. (Claremont, US). The FDA issued a Cleared decision on July 16, 2010 after a review of 149 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 Shanghai Mediworks Precision Instruments Co. , Ltd. devices

FDA 510(k) Submission Details - K100439

510(k) Number K100439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date July 16, 2010
Days to Decision 149 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
39d slower than avg
Panel avg: 110d · This submission: 149d
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
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