Cleared Traditional

K982599 - THE FREMSTAD RING

K982599 is an FDA 510(k) clearance for THE FREMSTAD RING, manufactured by Ophthalmic Solutions, LLC. The device is a Class 2 Ophthalmic device with product code HOZ cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K982599 · Ophthalmic Solutions, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
204d
Days
Class 2
Risk

K982599 is an FDA 510(k) clearance for the THE FREMSTAD RING. Classified as Sponge, Ophthalmic (product code HOZ), Class II - Special Controls.

Submitted by Ophthalmic Solutions, LLC (Tucker, US). The FDA issued a Cleared decision on February 16, 1999 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4790 - 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 Ophthalmic Solutions, LLC devices

FDA 510(k) Submission Details - K982599

510(k) Number K982599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date February 16, 1999
Days to Decision 204 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HOZ Device Classification - Class 2, Special Controls

Product Code HOZ Sponge, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4790
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 - HOZ Sponge, Ophthalmic

All 28
Devices cleared under the same product code (HOZ) and FDA review panel - the closest regulatory comparables to K982599.
SUNTOUCH EYE SPEAR
K132796 · Huizhou Foryou Medical Devices Co., Ltd. · Oct 2013
ULTRACELL ABSORBENT STICK
K012196 · Ultracell Medical Technologies, Inc. · Aug 2001
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
K011191 · Medtronic Xomed, Inc. · Jun 2001
HYDROFERA SURGICAL SPEAR
K974313 · Hydrofera, LLC · Mar 1998
ULTRACELL SUCTION SPONGE
K972633 · Ultracell Medical Technologies, Inc. · Dec 1997
DEROYAL INDUSTRIES, INC. SURGICAL EYE SPEAR
K972693 · Deroyal Industries, Inc. · Sep 1997