510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K193376Substantially Equivalent

Visalis V500, Visalis S500

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

K193376 is the FDA 510(k) clearance record for Visalis V500, Visalis S500, a class II device, cleared for Carl Zeiss Meditec, AG on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 78 510(k) clearances for Carl Zeiss Meditec, AG, from to . As of , FDA records show no recalls naming K193376.

Clearance record

Decision date
Received
(193 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, AG Goeschwitzer Strasse 51-52, Jena, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260