510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K024289Substantially Equivalent

Boston Bl-1000-Sim08 Multi-Action Solution

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

K024289 is the FDA 510(k) clearance record for BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION, a class II device, cleared for Bausch & Lomb, Incorporated on under FDA product code MRC (Products, Contact Lens Care, Rigid Gas Permeable). FDA records list 131 510(k) clearances for Bausch & Lomb, Incorporated, from to . As of , FDA records show no recalls naming K024289.

Clearance record

Decision date
Received
(130 days to decision)
Product code
MRC Products, Contact Lens Care, Rigid Gas Permeable
Regulation
21 CFR 886.5918
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Incorporated 1400 N. Goodman St., Rochester NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRC

Trailing 12 months

FDA records hold no clearances under product code MRC in the trailing twelve months.

FDA records show no clearances under product code MRC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MRC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260