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
K161194Substantially Equivalent

PLEX Elite 9000 SS-OCT

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

K161194 is the FDA 510(k) clearance record for PLEX Elite 9000 SS-OCT, a class II device, cleared for Carl Zeiss Meditec, Inc. on under FDA product code OBO (Tomography, Optical Coherence). FDA's definition for product code OBO reads: "Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases". FDA records list 78 510(k) clearances for Carl Zeiss Meditec, Inc., from to . As of , FDA records show one recall naming K161194.

Clearance record

Decision date
Received
(182 days to decision)
Product code
OBO Tomography, Optical Coherence
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Meditec, Inc. 5160 Hacienda Dr., Dublin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBO

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