510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061157Substantially Equivalent

Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens

Bausch & Lomb Incorporated, Rochester NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061157 is the FDA 510(k) clearance record for SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS, a class II device, cleared for Bausch & Lomb on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K061157.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb 1400 N. Goodman St., Rochester NY
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 November 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260