Cleared Traditional

K834060 - RELIANCE OPHTHALMIC SLIT LAMP R-083

K834060 is the FDA 510(k) clearance for RELIANCE OPHTHALMIC SLIT LAMP R-083 by F. & F. Koenigkramer. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K834060 · F. & F. Koenigkramer · Ophthalmic device
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Feb 1984
Decision
71d
Days
Class 2
Risk

K834060 is an FDA 510(k) clearance for the RELIANCE OPHTHALMIC SLIT LAMP R-083. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by F. & F. Koenigkramer (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 F. & F. Koenigkramer devices

Submission Details

510(k) Number K834060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date February 04, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 110d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 67
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