Cleared Traditional

K063750 - XCEL 255 SLIT LAMP

K063750 is an FDA 510(k) clearance for XCEL 255 SLIT LAMP, manufactured by Reichert, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K063750 · Reichert, Inc. · Ophthalmic device
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Dec 2006
Decision
1d
Days
Class 2
Risk

K063750 is an FDA 510(k) clearance for the XCEL 255 SLIT LAMP. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on December 20, 2006 after a review of 1 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 Reichert, Inc. devices

FDA 510(k) Submission Details - K063750

510(k) Number K063750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date December 20, 2006
Days to Decision 1 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 110d · This submission: 1d
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

Intertek Testing Services
NEIL E DEVINE, JR.

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
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