Cleared Traditional

K864063 - ORION 3001

K864063 is the FDA 510(k) clearance for ORION 3001 by G. Rodenstock Instrumente GmbH. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K864063 · G. Rodenstock Instrumente GmbH · Ophthalmic device
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Nov 1986
Decision
24d
Days
Class 2
Risk

K864063 is an FDA 510(k) clearance for the ORION 3001, LASER PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by G. Rodenstock Instrumente GmbH (Munchen 70, West Germany, DE). The FDA issued a Cleared decision on November 13, 1986 after a review of 24 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 G. Rodenstock Instrumente GmbH devices

Submission Details

510(k) Number K864063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1986
Decision Date November 13, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 110d · This submission: 24d
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 66
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