510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043150Substantially Equivalent

Amadeus II Epikeratome

Sis Ltd., Surgical Instrument Systems, Littleton CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043150 is the FDA 510(k) clearance record for AMADEUS II EPIKERATOME, a class I device, cleared for Sis Ltd., Surgical Instrument Systems on under FDA product code HNO (Keratome, Ac-Powered). FDA records list 3 510(k) clearances for Sis Ltd., Surgical Instrument Systems, from to . As of , FDA records show no recalls naming K043150.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Sis Ltd., Surgical Instrument Systems 13 Red Fox Ln., Littleton CO
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HNO, 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