Cleared Traditional

K070767 - EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION

K070767 is an FDA 510(k) clearance for EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION, manufactured by Lapis Lazuli International NV. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K070767 · Lapis Lazuli International NV · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
126d
Days
Class 2
Risk

K070767 is an FDA 510(k) clearance for the EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Lapis Lazuli International NV (Grand Junction,, US). The FDA issued a Cleared decision on July 24, 2007 after a review of 126 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.

FDA 510(k) Submission Details - K070767

510(k) Number K070767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date July 24, 2007
Days to Decision 126 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
16d slower than avg
Panel avg: 110d · This submission: 126d
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 K070767.
STERILE SALINE SOLUTION
K093367 · Cachet Pharmaceuticals Pvt. , Ltd. · Sep 2010
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
ALCON MULTI-PURPOSE SOLUTION
K071236 · Alcon, Inc. · Dec 2007
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
K070767 · EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
Download PDF FDA Summary Lapis Lazuli Internat…