510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K890080Substantially Equivalent

Phacoemulsifier Model 100

Sonic Needle Corp., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890080 is the FDA 510(k) clearance record for PHACOEMULSIFIER MODEL 100, a class II device, cleared for Sonic Needle Corp. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list one 510(k) clearance for Sonic Needle Corp. As of , FDA records show no recalls naming K890080.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Sonic Needle Corp. 1938 New Hwy., Farmingdale NY
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