Cleared Traditional

K980816 - RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

K980816 is an FDA 510(k) clearance for RETINAL DETACHMENT IMPLANTS, manufactured by Fci Ophthalmics, Inc.. The device is a Class 2 Ophthalmic device with product code HQX cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K980816 · Fci Ophthalmics, Inc. · Ophthalmic device
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Sep 1998
Decision
199d
Days
Class 2
Risk

K980816 is an FDA 510(k) clearance for the RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES. Classified as Implant, Orbital, Extra-ocular (product code HQX), Class II - Special Controls.

Submitted by Fci Ophthalmics, Inc. (Marshfield Hills, US). The FDA issued a Cleared decision on September 18, 1998 after a review of 199 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.3340 - 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 Fci Ophthalmics, Inc. devices

FDA 510(k) Submission Details - K980816

510(k) Number K980816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date September 18, 1998
Days to Decision 199 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 110d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQX Device Classification - Class 2, Special Controls

Product Code HQX Implant, Orbital, Extra-ocular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.3340
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 - HQX Implant, Orbital, Extra-ocular

Devices cleared under the same product code (HQX) and FDA review panel - the closest regulatory comparables to K980816.
OCU-GUARD AND OCU-GUARD SUPPLE
K983581 · Bio-Vascular, Inc. · Nov 1998
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
K950806 · Mira, Inc. · Jun 1996
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
K945172 · Visitec Co. · Jan 1995
SCLERAL BUCKLING IMPLANTS DIF/TYPES
K832481 · Storz Instrument Co. · Sep 1983
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140 · Dow Corning Corp. Healthcare Industries Materials · Mar 1980