Cleared Traditional

OPHTEC ENCLAVATION NEEDLE (K030471) - FDA 510(k) Clearance

Class I Ophthalmic device.

K030471 · Ophtec, USA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
64d
Days
Class 1
Risk

K030471 is an FDA 510(k) clearance for the OPHTEC ENCLAVATION NEEDLE. Classified as Hook, Ophthalmic (product code HNQ), Class I - General Controls.

Submitted by Ophtec, USA (Boca Raton, US). The FDA issued a Cleared decision on April 17, 2003 after a review of 64 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 Ophtec, USA devices

Submission Details

510(k) Number K030471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2003
Decision Date April 17, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HNQ Hook, 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.