510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854383Substantially Equivalent

Keratolux

Carl Zeiss, Inc., Thornwood NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854383 is the FDA 510(k) clearance record for KERATOLUX, a class I device, cleared for Carl Zeiss, Inc. on under FDA product code HPL (Device, Fixation, Ac-Powered, Ophthalmic). FDA's definition for product code HPL reads: "A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the...". FDA records list 44 510(k) clearances for Carl Zeiss, Inc., from to . As of , FDA records show no recalls naming K854383.

Clearance record

Decision date
Received
(13 days to decision)
Product code
HPL Device, Fixation, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1290
Device class
Class I
Review panel
Ophthalmic
Applicant
Carl Zeiss, Inc. One Zeiss Dr., Thornwood NY
Third party review
No

Clearances, product code HPL

Trailing 12 months

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

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