Cleared Traditional

K982115 - LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY

K982115 is an FDA 510(k) clearance for LENSERVER AUTOMATIC CONTACT LENS CLEANI..., manufactured by Rim-Wide Companies, Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K982115 · Rim-Wide Companies, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Jan 1999
Decision
211d
Days
Class 2
Risk

K982115 is an FDA 510(k) clearance for the LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Rim-Wide Companies, Inc. (San Diego, US). The FDA issued a Cleared decision on January 13, 1999 after a review of 211 days - an extended review cycle.

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 Rim-Wide Companies, Inc. devices

FDA 510(k) Submission Details - K982115

510(k) Number K982115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date January 13, 1999
Days to Decision 211 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
101d slower than avg
Panel avg: 110d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYL Device Classification - Class 2, Special Controls

Product Code LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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 - LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

All 10
Devices cleared under the same product code (LYL) and FDA review panel - the closest regulatory comparables to K982115.
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · Bausch & Lomb, Incorporated · May 2002
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · Strieter Clinical Research Laboratories, Inc. · Feb 2000
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · Purilens, Inc. · Oct 1999
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
K974724 · Lens Comfort, Inc. · Mar 1998
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
K964222 · Paladin Medical, Inc. · Dec 1996
NEW COMFORT CONTACT LENS CARE ACCESSORY
K962112 · Lens Comfort, Inc. · Nov 1996