510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K944895Substantially Equivalent

Bausch & Lomb Premier 90 (Balafilcon a) Contact Lens

Bausch & Lomb Incorporated, Rochester NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944895 is the FDA 510(k) clearance record for BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS, a class II device, cleared for Bausch & Lomb, Inc. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K944895.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 1400 N. Goodman St., Rochester NY
510(k) summary
Summary
Third party review
No

Clearances, product code LPL

Trailing 12 months
11 clearances under product code LPL in the twelve months to November 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LPL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20262
April 20261
May 20263
June 20260
July 20260
August 20260
September 20261
October 20262
November 20260