510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053475Substantially Equivalent

Optipoint Corneal Marker, Model Vpt-Opt-450

Refractec, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053475 is the FDA 510(k) clearance record for OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450, a class I device, cleared for Refractec, Inc. on under FDA product code HMR (Marker, Ocular). FDA records list 2 510(k) clearances for Refractec, Inc., from to . As of , FDA records show no recalls naming K053475.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HMR Marker, Ocular
Regulation
21 CFR 886.4570
Device class
Class I
Review panel
Ophthalmic
Applicant
Refractec, Inc. 5 Jenner, Suite 150, Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code HMR

Trailing 12 months

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

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