Cleared Traditional

K071203 - SEREINE EXTRA STRENGTH DAILY CLEANER FO...

K071203 is the FDA 510(k) clearance for SEREINE EXTRA STRENGTH DAILY CLEANER FO... by Optikem International, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K071203 · Optikem International, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
43d
Days
Class 2
Risk

K071203 is an FDA 510(k) clearance for the SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTAC.... Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Optikem International, Inc. (Grand Junction, US). The FDA issued a Cleared decision on June 13, 2007 after a review of 43 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.

View all Optikem International, Inc. devices

Submission Details

510(k) Number K071203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2007
Decision Date June 13, 2007
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K071203.
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