510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000327Unknown

Wavescan Wavefront System Model Hs 1

Visx, Incorporated, Santa Ana CA / Traditional, Unknown
FDA source (opens on fda.gov)

K000327 is the FDA 510(k) clearance record for WAVESCAN WAVEFRONT SYSTEM MODEL HS 1, a class I device, cleared for Visx, Incorporated on under FDA product code HKO (Refractometer, Ophthalmic). FDA records list 2 510(k) clearances for Visx, Incorporated, from to . As of , FDA records show no recalls naming K000327.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HKO Refractometer, Ophthalmic
Regulation
21 CFR 886.1760
Device class
Class I
Review panel
Ophthalmic
Applicant
Visx, Incorporated 3400 Central Expy., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code HKO

Trailing 12 months

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

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