510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000457Substantially Equivalent

Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic Therapy Pak, Model 12000 Series

Retinalabs.Com, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000457 is the FDA 510(k) clearance record for VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES, a class I device, cleared for Retinalabs.Com on under FDA product code HMX (Cannula, Ophthalmic). FDA records list 5 510(k) clearances for Retinalabs.Com, from to . As of , FDA records show no recalls naming K000457.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HMX Cannula, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Retinalabs.Com 1776 Peachtree St., Atlanta GA
510(k) summary
Summary
Third party review
No

Clearances, product code HMX

Trailing 12 months

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

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