Ilco Infrared Light Coagulator

FDA 510(k) K911600 · Holl Meditronics, Inc.

Substantially Equivalent

510(k) numberK911600

Submission

Device name
Ilco Infrared Light Coagulator
Applicant
Holl Meditronics, Inc.
Bolton, Ontario, CA
Received
April 10, 1991
Decision date
July 9, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

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K893924Moto-Med Rf-Ii and PicoBXB · Traditional 11/27/1990SE
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Questions and answers

When was Ilco Infrared Light Coagulator cleared by the FDA?

Ilco Infrared Light Coagulator (K911600) received a 510(k) decision of Substantially Equivalent on July 9, 1991, 90 days after the submission was received.

What is the product code of K911600?

The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.