510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K953245Substantially Equivalent

Nyx Golf Vision System

Nyx Golf, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953245 is the FDA 510(k) clearance record for NYX GOLF VISION SYSTEM, a class I device, cleared for Nyx Golf, Inc. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Nyx Golf, Inc. As of , FDA records show no recalls naming K953245.

Clearance record

Decision date
Received
(12 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Nyx Golf, Inc. 5010 Purdue, Dallas TX
510(k) summary
Statement
Third party review
No

Clearances, product code HQY

Trailing 12 months

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

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