Iris Nd:Yag Opthalmic Laser

Q: What is the product code of K883270?

The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.

FDA 510(k) K883270 · California Laboratories, Inc.

Substantially Equivalent

510(k) numberK883270

Submission

Device name: Iris Nd:Yag Opthalmic Laser
Applicant: California Laboratories, Inc.
Carlsbad, CA, US
Received: August 3, 1988
Decision date: October 13, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.4390
Specialty: Ophthalmic

Other 510(k)s with product code LQJ

510(k)	Device	Applicant	Decision
K163632	Katalyst Cyclophotocoagulation ProbeLQJ · Traditional	Katalyst Surgical, LLC	06/15/2017SE
K931356	Safe Air Vari-Spot Handpiece Telescope and AdaptorLQJ · Traditional	Sorenson Laboratories, Inc.	09/07/1993SE
K921414	Trokel /3 Gonio Laser LensLQJ · Traditional	Ocular Instruments, Inc.	11/16/1992SE
K912112	PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480LQJ · Traditional	Tomey Corporation USA	06/17/1991SE
K893731	Shields T.C. Laser LensLQJ · Traditional	Ocular Instruments, Inc.	08/17/1989SE
K884694	MQL 20 Nd:Yag Ophthalmic LaserLQJ · Traditional	California Laboratories, Inc.	11/30/1988SE
K883719	Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional	Biophysic Medical, Inc.	10/18/1988SE
K882574	Boldrey Peripheral Retinal LensLQJ · Traditional	Ocular Instruments, Inc.	07/29/1988SE
K872802	Trokel Single Mirror Yag Laser LensLQJ · Traditional	Ocular Instruments, Inc.	09/04/1987SE
K871245	Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1LQJ · Traditional	Chiron Vision Corp.	05/07/1987SE

More from Chiron Vision Corp.

510(k)	Device	Decision
K884431	Hexascan Handpiece for Argon/Dye LaserGEX · Traditional	12/02/1988SE
K884694	MQL 20 Nd:Yag Ophthalmic LaserLQJ · Traditional	11/30/1988SE
K875338	Chrys(Tm) Model Med-MaxGEX · Traditional	04/13/1988SE

Questions and answers

When was Iris Nd:Yag Opthalmic Laser cleared by the FDA?

Iris Nd:Yag Opthalmic Laser (K883270) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 71 days after the submission was received.

What is the product code of K883270?

The FDA product code is LQJ – Lens, Surgical, Laser, Accesssory, Ophthalmic Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.