510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884362Substantially Equivalent

Labeling Changes to Fyodorov Collagen Corneal Shld

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

K884362 is the FDA 510(k) clearance record for LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD, a class II device, cleared for Bausch & Lomb Pharmaceutical, Inc. on under FDA product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)). FDA records list 6 510(k) clearances for Bausch & Lomb Pharmaceutical, Inc., from to . As of , FDA records show no recalls naming K884362.

Clearance record

Decision date
Received
(40 days to decision)
Product code
HQJ Implant, Absorbable, (Scleral Buckling Methods)
Regulation
21 CFR 886.3300
Device class
Class II
Review panel
Ophthalmic
Applicant
Bausch & Lomb Pharmaceutical, Inc. 11300 49th St., N., Clearwater FL
Third party review
No

Clearances, product code HQJ

Trailing 12 months

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

FDA records show no clearances under product code HQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQJ, 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