510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000637Unknown

Customcornea Measurement Device (Ccmd)

Alcon Laboratories, Orlando FL / Traditional, Unknown
FDA source (opens on fda.gov)

K000637 is the FDA 510(k) clearance record for CUSTOMCORNEA MEASUREMENT DEVICE (CCMD), a class I device, cleared for Alcon Laboratories, Inc. on under FDA product code NCF (Aberrometer, Ophthalmic). FDA records list 152 510(k) clearances for Alcon Laboratories, Inc., from to . As of , FDA records show no recalls naming K000637.

Clearance record

Decision date
Received
(84 days to decision)
Product code
NCF Aberrometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Alcon Laboratories, Inc. 2800 Discovery Dr.,, Orlando FL
510(k) summary
Statement
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