Light Commander

FDA 510(k) K960767 · Scieran Technologies, Inc.

Substantially Equivalent

510(k) numberK960767

Submission

Device name
Light Commander
Applicant
Scieran Technologies, Inc.
Laguna Hills, CA, US
Received
February 26, 1996
Decision date
August 26, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FCT – Headlight, Fiberoptic Focusing
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4335
Specialty
Ophthalmic

Other 510(k)s with product code FCT

510(k)DeviceApplicantDecision
K924198Modified Site Fiber Optic ModuleFCT · Traditional Chiron Vision Corp.11/23/1992SE
K883480Modified Site Fiber Optic Module for Ophthal. UseFCT · Traditional Site Microsurgical Systems, Inc.08/24/1988SE
K802770Fiber Optic Headlight #60-0766766FCT · Traditional Aspen Laboratories, Inc.12/11/1980SE
K802769Fiber Optic Headlight #60-0765FCT · Traditional Aspen Laboratories, Inc.12/11/1980SE
K780433Fiber Optic Adjustable HeadlightFCT · Traditional Cameron-Miller, Inc.06/13/1978SE

More from Cameron-Miller, Inc.

510(k)DeviceDecision
K974253CPD CommanderMRH · Traditional 02/25/1998SE
K980085Phaco CommanderHQC · Traditional 02/24/1998SE
K973749Frag CommanderHQC · Traditional 12/08/1997SE
K961738Vit Commander SystemHQE · Traditional 11/25/1996SE

Questions and answers

When was Light Commander cleared by the FDA?

Light Commander (K960767) received a 510(k) decision of Substantially Equivalent on August 26, 1996, 182 days after the submission was received.

What is the product code of K960767?

The FDA product code is FCT – Headlight, Fiberoptic Focusing, a Class II (moderate risk) device regulated under 21 CFR 886.4335.