510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912904Substantially Equivalent

Mentor Odyssey Phacoemulsification System

Mentor O & O, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912904 is the FDA 510(k) clearance record for MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM, a class II device, cleared for Mentor O & O, Inc. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 18 510(k) clearances for Mentor O & O, Inc., from to . As of , FDA records show no recalls naming K912904.

Clearance record

Decision date
Received
(345 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Mentor O & O, Inc. 3000 Longwater Dr., Norwell MA
510(k) summary
Statement
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260