510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001772Substantially Equivalent

Laserex Era Articulated Arm Kit, Model Lqp4106-Aa

Taracan Pty., Ltd., Adelaide, South Australia, AU / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001772 is the FDA 510(k) clearance record for LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA, a class II device, cleared for Taracan Pty. , Ltd. on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Taracan Pty. , Ltd. As of , FDA records show no recalls naming K001772.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Taracan Pty. , Ltd. 258 Halifax St., Adelaide, South Australia, AU
510(k) summary
Statement
Third party review
No

Clearances, product code HQF

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