Cleared Traditional

K991965 - PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES

K991965 is an FDA 510(k) clearance for PURILENS SYSTEM FOR CLEANING AND DISINF..., manufactured by Purilens, Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K991965 · Purilens, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
113d
Days
Class 2
Risk

K991965 is an FDA 510(k) clearance for the PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Purilens, Inc. (Rockville, US). The FDA issued a Cleared decision on October 1, 1999 after a review of 113 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 Purilens, Inc. devices

FDA 510(k) Submission Details - K991965

510(k) Number K991965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1999
Decision Date October 01, 1999
Days to Decision 113 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
3d slower than avg
Panel avg: 110d · This submission: 113d
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 K991965.
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · Ciba Vision Corporation · Nov 2002
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
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
K982115 · Rim-Wide Companies, Inc. · Jan 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