510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K772168Substantially Equivalent

Moldeye

Robert B. Scott Ocularists of Florida, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K772168 is the FDA 510(k) clearance record for MOLDEYE, a class II device, cleared for Robert B. Scott Ocularists of Florida, Inc. on under FDA product code HQN (Conformer, Ophthalmic). FDA records list 2 510(k) clearances for Robert B. Scott Ocularists of Florida, Inc., from to . As of , FDA records show no recalls naming K772168.

Clearance record

Decision date
Received
(22 days to decision)
Product code
HQN Conformer, Ophthalmic
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Robert B. Scott Ocularists of Florida, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HQN

Trailing 12 months

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

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