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
K062930Substantially Equivalent

Ladarwave Customcornea Wavefront System

Alcon Laboratories, Orlando FL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062930 is the FDA 510(k) clearance record for LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM, a class I device, cleared for Alcon Research, Ltd. on under FDA product code NCF (Aberrometer, Ophthalmic). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K062930.

Clearance record

Decision date
Received
(41 days to decision)
Product code
NCF Aberrometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Alcon Research, Ltd. 2501 Discovery Dr.,, Orlando FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCF

Trailing 12 months

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

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