510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031404Substantially Equivalent

Dignity Ophthalmic Surgical System

Phacor Inc., A Santen Company, San Luis Obispo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031404 is the FDA 510(k) clearance record for DIGNITY OPHTHALMIC SURGICAL SYSTEM, a class II device, cleared for Phacor Inc., A Santen Company on under FDA product code HQC (Unit, Phacofragmentation). FDA records list one 510(k) clearance for Phacor Inc., A Santen Company. As of , FDA records show no recalls naming K031404.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Phacor Inc., A Santen Company 775 Fiero Ln., San Luis Obispo CA
510(k) summary
Summary PDF
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