Cleared Traditional

K062332 - ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION

K062332 is an FDA 510(k) clearance for ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS..., manufactured by Altaire Pharmaceuticals, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K062332 · Altaire Pharmaceuticals, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
258d
Days
Class 2
Risk

K062332 is an FDA 510(k) clearance for the ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Altaire Pharmaceuticals, Inc. (Grand Junction, US). The FDA issued a Cleared decision on April 25, 2007 after a review of 258 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.

FDA 510(k) Submission Details - K062332

510(k) Number K062332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2006
Decision Date April 25, 2007
Days to Decision 258 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 110d · This submission: 258d
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 K062332.
ALCON MULTI-PURPOSE SOLUTION
K071236 · Alcon, Inc. · Dec 2007
EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION
K070767 · Lapis Lazuli International NV · Jul 2007
SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
K071203 · Optikem International, Inc. · Jun 2007
JSZ MULTIACTION GP CONTACT LENS SOLUTION
K060924 · Szabocsik and Associates · Jun 2006
EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
K051104 · Lapis Lazuli, NV · May 2006
ALCON MULTI-PURPOSE DISINFECTING SOLUTION
K050729 · Alcon Research, Ltd. · Sep 2005
K062332 · ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
Download PDF FDA Summary Altaire Pharmaceutica…