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
K864369Substantially Equivalent

Lts Corneal Microscope Laser Tomographic Scanner

Heidelberg Instruments, La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864369 is the FDA 510(k) clearance record for LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER, a class I device, cleared for Heidelberg Instruments on under FDA product code HJB (Instrument, Measuring, Corneal Radius). FDA records list one 510(k) clearance for Heidelberg Instruments. As of , FDA records show no recalls naming K864369.

Clearance record

Decision date
Received
(40 days to decision)
Product code
HJB Instrument, Measuring, Corneal Radius
Regulation
21 CFR 886.1450
Device class
Class I
Review panel
Ophthalmic
Applicant
Heidelberg Instruments Univ. Of California, San Diego, La Jolla CA
Third party review
No

Clearances, product code HJB

Trailing 12 months

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

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