Cleared Traditional

K073190 - SLIT LAMP

K073190 is an FDA 510(k) clearance for SLIT LAMP, manufactured by Huvitz Co., Ltd.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K073190 · Huvitz Co., Ltd. · Ophthalmic device
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Jan 2008
Decision
59d
Days
Class 2
Risk

K073190 is an FDA 510(k) clearance for the SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Huvitz Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on January 11, 2008 after a review of 59 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 Huvitz Co., Ltd. devices

FDA 510(k) Submission Details - K073190

510(k) Number K073190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date January 11, 2008
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 85
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K073190.
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