Safe Air Vari-Spot Handpiece Telescope and Adaptor

FDA 510(k) K931356 · Sorenson Laboratories, Inc.

Substantially Equivalent

510(k) numberK931356

Submission

Device name
Safe Air Vari-Spot Handpiece Telescope and Adaptor
Applicant
Sorenson Laboratories, Inc.
Salt Lake City, UT, US
Received
March 17, 1993
Decision date
September 7, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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K884694MQL 20 Nd:Yag Ophthalmic LaserLQJ · Traditional California Laboratories, Inc.11/30/1988SE
K883719Interconn. of Ophthalas & Nanolas Laser SystemLQJ · Traditional Biophysic Medical, Inc.10/18/1988SE
K883270Iris Nd:Yag Opthalmic LaserLQJ · Traditional California Laboratories, Inc.10/13/1988SE
K882574Boldrey Peripheral Retinal LensLQJ · Traditional Ocular Instruments, Inc.07/29/1988SE
K872802Trokel Single Mirror Yag Laser LensLQJ · Traditional Ocular Instruments, Inc.09/04/1987SE
K871245Laser Contact Lenses Cga 1, Cgi 1, CGP 1, CGV 1LQJ · Traditional Chiron Vision Corp.05/07/1987SE

More from Chiron Vision Corp.

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Questions and answers

When was Safe Air Vari-Spot Handpiece Telescope and Adaptor cleared by the FDA?

Safe Air Vari-Spot Handpiece Telescope and Adaptor (K931356) received a 510(k) decision of Substantially Equivalent on September 7, 1993, 174 days after the submission was received.

What is the product code of K931356?

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