Cleared Traditional

K914483 - WETTING SOLUTION FOR HARD CONTACT LENSES

K914483 is an FDA 510(k) clearance for WETTING SOLUTION FOR HARD CONTACT LENSES, manufactured by Optopics Laboratories Corp.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K914483 · Optopics Laboratories Corp. · Ophthalmic device
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Feb 1992
Decision
120d
Days
Class 2
Risk

K914483 is an FDA 510(k) clearance for the WETTING SOLUTION FOR HARD CONTACT LENSES. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Optopics Laboratories Corp. (Fairton, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Optopics Laboratories Corp. devices

FDA 510(k) Submission Details - K914483

510(k) Number K914483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date February 05, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 91
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K914483.
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · Polymer Technology Corp. · Nov 1997
BOSTON CONDITIONING SOLUTION
K923438 · Polymer Technology Corp. · Dec 1992
BOSTON CLEANER II
K923437 · Polymer Technology Corp. · Oct 1992
OPTI-TEARS(R)
K890303 · Alcon Laboratories · Feb 1989
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · Bausch & Lomb, Inc. · Nov 1987
OPTI-ZYME(R)
K873548 · Alcon Laboratories · Sep 1987