510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130331Substantially Equivalent

Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

Sauflon Pharmaceuticals, Ltd., Twickenham, Middlesex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130331 is the FDA 510(k) clearance record for SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER, a class II device, cleared for Sauflon Pharmaceuticals, Ltd. on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 12 510(k) clearances for Sauflon Pharmaceuticals, Ltd., from to . As of , FDA records show 16 recalls naming K130331.

Clearance record

Decision date
Received
(165 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Sauflon Pharmaceuticals, Ltd. 49-53 York St., Twickenham, Middlesex, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVN

Trailing 12 months
1 clearance under product code MVN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260