510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945270Substantially Equivalent

Custom Artificial Human Eyes

Daniel T Acosta, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945270 is the FDA 510(k) clearance record for CUSTOM ARTIFICIAL HUMAN EYES, a class I device, cleared for Daniel T Acosta on under FDA product code HQH (Eye, Artificial, Non-Custom). FDA records list one 510(k) clearance for Daniel T Acosta. As of , FDA records show no recalls naming K945270.

Clearance record

Decision date
Received
(214 days to decision)
Product code
HQH Eye, Artificial, Non-Custom
Regulation
21 CFR 886.3200
Device class
Class I
Review panel
Ophthalmic
Applicant
Daniel T Acosta 2244 Fourth Ave., Suite E, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code HQH

Trailing 12 months

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

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