Question 1

Who is the manufacturer of LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA?

Accepted Answer

Taracan Pty. , Ltd. submitted the Special clearance for LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA (K001772).

Question 2

What is the FDA product code for LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA?

Accepted Answer

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

Question 3

When was LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA cleared by the FDA?

Accepted Answer

Jul 6, 2000 (decision: SESE).

Question 4

What is the regulatory pathway for LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA?

Accepted Answer

510(k) clearance (submission type: Special).

Record ID	K001772
Device Name	LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
Applicant	Taracan Pty. , Ltd.
Product Code	HQF · Ophthalmic
Decision Date	Jul 6, 2000
Decision	SESE
Submission Type	Special
Regulation	21 CFR 886.4390
Device Class	Class 2

LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

Device Facts