K130734 is an FDA 510(k) clearance for the SAUFLON MULTIPURPOSE SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.
Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on May 15, 2013 after a review of 58 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.
NCT01392937
Completed
Interventional
Industry-sponsored
Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses
The Clinical Performance of the All-in-One Light Multi-purpose Care Regimen for Silicone Hydrogel Contact Lenses
| Condition studied |
Healthy |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Philip Morgan, PhD |
| Sponsor |
Sauflon Pharmaceuticals Ltd
(industry)
|
Started 2010-03-01
→
Primary completion 2010-04-01
→
Completed 2011-03-01
Primary outcome
Overall subjective acceptance.
Study completed - no results published.
This trial concluded in 2011 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov