510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896685Substantially Equivalent

Bausch & Lomb Frequent Replacement Case System

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

K896685 is the FDA 510(k) clearance record for BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM, a class II device, cleared for Bausch & Lomb, Inc. on under FDA product code LRX (Case, Contact Lens). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K896685.

Clearance record

Decision date
Received
(28 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 1400 N. Goodman St., Rochester NY
Third party review
No

Clearances, product code LRX

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