510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991840Substantially Equivalent

Fresco Phosphene Tonometer and or Phosphene Tonometer and or Fpt and or Eyelid Tonometer

Bernard B. Fresco, Toronto, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991840 is the FDA 510(k) clearance record for FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER, a class II device, cleared for Bernard B. Fresco on under FDA product code HKY (Tonometer, Manual). FDA records list one 510(k) clearance for Bernard B. Fresco. As of , FDA records show no recalls naming K991840.

Clearance record

Decision date
Received
(297 days to decision)
Product code
HKY Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Bernard B. Fresco 40 Saint Clair Ave. E. 303, Toronto, Ontario, CA
510(k) summary
Summary
Third party review
No

Clearances, product code HKY

Trailing 12 months

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

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