Cleared Traditional

K861491 - ROPHAE DIAMOND KNIFE

K861491 is the FDA 510(k) clearance for ROPHAE DIAMOND KNIFE by Rophae Lens Co., Inc.. It is a Class 1 Ophthalmic device (product code HNN) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K861491 · Rophae Lens Co., Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
36d
Days
Class 1
Risk

K861491 is an FDA 510(k) clearance for the ROPHAE DIAMOND KNIFE. Classified as Knife, Ophthalmic (product code HNN), Class I - General Controls.

Submitted by Rophae Lens Co., Inc. (St. Petersburg, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Rophae Lens Co., Inc. devices

Submission Details

510(k) Number K861491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date May 28, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNN Knife, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HNN Knife, Ophthalmic

All 21
Devices cleared under the same product code (HNN) and FDA review panel - the closest regulatory comparables to K861491.
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
K864290 · Keeler Instruments, Inc. · Dec 1986
SAPPHIRE KNIFE BLADE
K861744 · Keeler Instruments, Inc. · Jun 1986
RUBY & SAPPHIRE BLADE HOLDER
K861748 · Keeler Instruments, Inc. · Jun 1986
STORZ E9050 & E9055 DIAMOND KNIVES
K861732 · Storz Instrument Co. · May 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · Storz Instrument Co. · Mar 1986
SMARTKNIFE SYSTEM
K853063 · CooperVision, Inc. · Nov 1985