Cleared Traditional

K861535 - OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU

K861535 is an FDA 510(k) clearance for OPTICAL MARKERS/FIXATION RING/CANNU & I..., manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code HMR cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K861535 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
20d
Days
Class 1
Risk

K861535 is an FDA 510(k) clearance for the OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU. Classified as Marker, Ocular (product code HMR), Class I - General Controls.

Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on May 14, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4570 - 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K861535

510(k) Number K861535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date May 14, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

HMR Device Classification - Class 1, General Controls

Product Code HMR Marker, Ocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4570
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.