510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021640Substantially Equivalent

Hansatome Excellus Microkeratome

Bausch & Lomb Incorporated, St. Louis MO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021640 is the FDA 510(k) clearance record for HANSATOME EXCELLUS MICROKERATOME, a class I device, cleared for Bausch & Lomb, Inc. on under FDA product code HNO (Keratome, Ac-Powered). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K021640.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 3365 Tree Ct. Industrial Blvd., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HNO

Trailing 12 months

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

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