510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884364Substantially Equivalent

Labeling Changes to Bio-Cor Ext Collangen Corneal

Bausch & Lomb Pharmaceutical, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884364 is the FDA 510(k) clearance record for LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL, a class I device, cleared for Bausch & Lomb Pharmaceutical, Inc. on under FDA product code MOE (Collagen Corneal Shield). FDA records list 6 510(k) clearances for Bausch & Lomb Pharmaceutical, Inc., from to . As of , FDA records show no recalls naming K884364.

Clearance record

Decision date
Received
(40 days to decision)
Product code
MOE Collagen Corneal Shield
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Applicant
Bausch & Lomb Pharmaceutical, Inc. 11300 49th St., N., Clearwater FL
Third party review
No

Clearances, product code MOE

Trailing 12 months

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

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