Cleared Traditional

K051104 - EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION

K051104 is an FDA 510(k) clearance for EYE SEE MULTIPURPOSE, manufactured by Lapis Lazuli, NV. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 394-day FDA review.

K051104 · Lapis Lazuli, NV · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
394d
Days
Class 2
Risk

K051104 is an FDA 510(k) clearance for the EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Lapis Lazuli, NV (Grand Junction, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K051104

510(k) Number K051104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2005
Decision Date May 31, 2006
Days to Decision 394 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
284d slower than avg
Panel avg: 110d · This submission: 394d
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 K051104.
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
K071203 · Optikem International, Inc. · Jun 2007
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
K062332 · Altaire Pharmaceuticals, Inc. · Apr 2007
JSZ MULTIACTION GP CONTACT LENS SOLUTION
K060924 · Szabocsik and Associates · Jun 2006
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
AQUIFY MULTIPURPOSE SOLUTION
K050250 · Ciba Vision Corporation · Aug 2005
LENS PLUS REWETTING DROPS
K042562 · Advanced Medical Optics, Inc. · Jul 2005
K051104 · EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
Download PDF FDA Summary Lapis Lazuli, NV