510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100253Substantially Equivalent

Visumax Laser Keratome

Carl Zeiss Meditec Inc, Dublin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100253 is the FDA 510(k) clearance record for VISUMAX LASER KERATOME, a class II device, cleared for Carl Zeiss Meditec, AG on under FDA product code HQF (Laser, Ophthalmic). FDA records list 78 510(k) clearances for Carl Zeiss Meditec, AG, from to . As of , FDA records show one recall naming K100253.

Clearance record

Decision date
Received
(161 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, AG 5160 Hacienda Dr., Dublin CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HQF

Trailing 12 months
2 clearances under product code HQF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260