510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162756Substantially Equivalent

PHAKOS Disposable Retinal Cryo Probe

Phakos, Montreuil, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162756 is the FDA 510(k) clearance record for PHAKOS Disposable Retinal Cryo Probe, a class II device, cleared for Phakos on under FDA product code HRN (Unit, Cryophthalmic, Ac-Powered). FDA records list 4 510(k) clearances for Phakos, from to . As of , FDA records show no recalls naming K162756.

Clearance record

Decision date
Received
(215 days to decision)
Product code
HRN Unit, Cryophthalmic, Ac-Powered
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Phakos 62 Rue Kleber, Montreuil, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRN

Trailing 12 months

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

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