Cleared Traditional

K071236 - ALCON MULTI-PURPOSE SOLUTION

K071236 is an FDA 510(k) clearance for ALCON MULTI-PURPOSE SOLUTION, manufactured by Alcon, Inc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K071236 · Alcon, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
223d
Days
Class 2
Risk

K071236 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon, Inc. (Fort Worth, US). The FDA issued a Cleared decision on December 12, 2007 after a review of 223 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 - K071236

510(k) Number K071236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date December 12, 2007
Days to Decision 223 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
113d slower than avg
Panel avg: 110d · This submission: 223d
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 114
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K071236.
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
K093254 · Abbott Medical Optics, Inc. · Sep 2010
STERILE SALINE SOLUTION
K093367 · Cachet Pharmaceuticals Pvt. , Ltd. · Sep 2010
REFRESH OPTIVE LENS COMFORT REWETTING DROPS
K083812 · Allergan, Inc. · Jul 2009
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
ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION
K062332 · Altaire Pharmaceuticals, Inc. · Apr 2007
K071236 · ALCON MULTI-PURPOSE SOLUTION
Download PDF FDA Summary Alcon, Inc.