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FDA 510(k)

Sterling Supreme Diode Laser

K-Number: K181614 · 2019-09-10

ApplicantCAO Group, Inc.
Decision Date2019-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterling Supreme Diode Laser is the device name listed in this FDA 510(k) record. The listed applicant is CAO Group, Inc.. It received FDA 510(k) clearance on 2019-09-10 under 510(k) number K181614. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterling Supreme Diode Laser?

Sterling Supreme Diode Laser is a medical device that received FDA 510(k) clearance on 2019-09-10. The listed applicant is CAO Group, Inc.. The 510(k) number is K181614.

When did Sterling Supreme Diode Laser receive FDA 510(k) clearance?

Sterling Supreme Diode Laser received FDA 510(k) clearance on 2019-09-10, under 510(k) number K181614.

Who is the listed applicant for Sterling Supreme Diode Laser?

The FDA 510(k) record lists CAO Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterling Supreme Diode Laser?

The FDA product code for Sterling Supreme Diode Laser is GEX. This falls under the Gastroenterology category.

Other records listing CAO Group, Inc. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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