510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945110Substantially Equivalent

Kolberg Ophthalmic Conformer

Kolberg Ocular Products, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945110 is the FDA 510(k) clearance record for KOLBERG OPHTHALMIC CONFORMER, a class II device, cleared for Kolberg Ocular Products, Inc. on under FDA product code HQN (Conformer, Ophthalmic). FDA records list one 510(k) clearance for Kolberg Ocular Products, Inc. As of , FDA records show no recalls naming K945110.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HQN Conformer, Ophthalmic
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Kolberg Ocular Products, Inc. 9663 Tierra Grande St.,, San Diego CA
510(k) summary
Summary
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