510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K862021Substantially Equivalent

Phacoemulsification Ultrasonic Fragment System

Ultramed, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862021 is the FDA 510(k) clearance record for PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM, a class II device, cleared for Ultramed, Inc. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 5 510(k) clearances for Ultramed, Inc., from to . As of , FDA records show no recalls naming K862021.

Clearance record

Decision date
Received
(26 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Ultramed, Inc. 13117 Quate Ct., Poway CA
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