Cleared Traditional

HA ORBITAL IMPLANT (K021643) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021643 · Laboratoire Villanova · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
207d
Days
Class 2
Risk

K021643 is an FDA 510(k) clearance for the HA ORBITAL IMPLANT. Classified as Implant, Eye Sphere (product code HPZ), Class II - Special Controls.

Submitted by Laboratoire Villanova (Le Touquet, FR). The FDA issued a Cleared decision on December 13, 2002 after a review of 207 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3320 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Laboratoire Villanova devices

Submission Details

510(k) Number K021643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date December 13, 2002
Days to Decision 207 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
97d slower than avg
Panel avg: 110d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HPZ Implant, Eye Sphere
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3320
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.