Cleared Traditional

K002319 - PURILENS SALINE SOLUTION

K002319 is an FDA 510(k) clearance for PURILENS SALINE SOLUTION, manufactured by Purilens, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K002319 · Purilens, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
30d
Days
Class 2
Risk

K002319 is an FDA 510(k) clearance for the PURILENS SALINE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Purilens, Inc. (New Port Riche, US). The FDA issued a Cleared decision on August 30, 2000 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002319

510(k) Number K002319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2000
Decision Date August 30, 2000
Days to Decision 30 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
80d faster than avg
Panel avg: 110d · This submission: 30d
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 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K002319.
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K003109 · Allergan, Inc. · Nov 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · Alcon Universal, Ltd. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K001214 · Alcon Universal, Ltd. · Jul 2000
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES
K000998 · Optisonic, Inc. · Jun 2000
K002319 · PURILENS SALINE SOLUTION
Download PDF FDA Summary Purilens, Inc.